PharmaShots’ Key Highlights of Third Quarter 2019

Duplicate This Shiwani Sharma Latest, MedTech 510(k), Ambulatory Physiologic Monitoring, Biofourmis, Biovitals Analytics Engine, Clearance, FDA, receives 0 —No comments Published 2 mins ago 1 0 Needs improvement Needs improvement Select PharmaShots’ Key Highlights of Third Quarter 2019 “PharmaShots’ Key Highlights of Third Quarter 2019” is locked PharmaShots’ Key Highlights of Third Quarter 2019

The third quarter of 2019 has ended with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisition where Biocon Biologics acquires Pfizer’s Research Facility for expansion of its R&D footprints with the acceleration of the development of its biosimilars from lab to pilot scale. Previously, Amgen acquired Celgene’s Otezla (apremilast) for $13.4B to dispel the apprehensions lifted by the U.S. Federal Trade Commission due to a contending treatment being developed. Additionally, Bayer signed a license agreement with Informed Data Systems utilizing One Drop’s Digital Therapeutics platform for a better understanding of healthcare outcomes for patients with chronic conditions. The quarter also rolled major approvals for biosimilars i.e Samsung Bioepis’ Hadlima (biosimilar, adalimumab) received FDA’s approval for autoimmune diseases as well as Teva Canada’s Herzuma (biosimilar, trastuzumab) received Health Canada’s for multiple cancer indications. Our team at PharmaShots has summarized and complied with the insights of Q3’19.

1.SIFI Acquired Laboratoire Gifrer Barbezat’s Dacudoses and Novoptine for $6.7M in France

Date – July 04, 2019

Deal Value – $6.7M

  • SIFI acquired two leading ophthalmic antiseptic candidates of Gifrer Barbezat for a total value of $6.7M and will be available in the French market from Jan’2020 through its subsidiary SIFI France
  • The focus of the acquisition is to expand SIFI’s ophthalmic portfolio with the addition of Grifer’s Dacudoses & Novoptine products and to accelerate the expansion of SIFI’s footprints in the French market
  • Dacudoses is used as an eyewash in case of conjunctivitis whereas Novoptine is an OTC antiseptic collyrium indicated for the treatment of eye infections and conjunctivitis

2.AbbVie Acquired Mavupharma for its STING (STimulator of INterferon Genes) Modulators to Treat Cancer

 Date – July 15, 2019

Product – STING (STimulator of INterferon Genes)

  • AbbVie has acquired Mavupharma to develop STING modulators and to advance Mavupharma’s lead candidate MAVU-104 towards clinical study
  • The focus of the acquisition was to bolster AbbVie’s early-stage oncology portfolio with the addition of Mavupharma’s platform which involved the development of transformative therapies for cancer patients
  • MAVU-104 is an orally administered ENPP1 inhibitor allowing highly controlled enhancement of STING signaling in tumors without the need for injections.

3.Abbott’s MitraClip G4 Received the US FDA’s Approval for the Treatment of Mitral Regurgitation

Date – July 15, 2019

Product – MitraClip G4

  • MitraClip G4 is a fourth-generation MitraClip device offering a new option to physicians for treating leaky mitral valve in the US with an expanded range of clip sizes and leaflet grasping feature
  • MitraClip G4 provides the benefit of an upgraded catheter to allow integrated real-time continuous left atrial pressure monitoring during implant and help physicians to determine the accurate position of MitraClip for optimizing patient outcomes
  • Mitraclip is a device used to prevent backflow of blood and restore the heart’s ability to pump oxygenated blood more efficiently and has received the FDA’s approval for primary and secondary MR in 2013 and 2019 respectively.

4.Baxter’s Myxredlin Ready-To-Use Insulin for IV Infusion Received FDA’s Approval for Diabetes Mellitus

Date – July 23, 2019

Product – Myxredlin

  • The US FDA has granted approval to Myxredlin as the first ready-to-use insulin for IV infusion in the hospital with an extended shelf-life of 30 days @25◦C or 24 months if refrigerated @2-8◦C
  • Myxredlin utilizes Baxter’s Galaxy container technology which is a non-PVC and non-DEHP system enabling premixed medicines to have a longer shelf life at room temperature
  • Myxredlin (insulin human in 0.9% sodium chloride injection) is available in a standardized concentration of 100 units/100 mL in a flexible plastic container indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

5.Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Received FDA’s Approval for Autoimmune Diseases

Date – July 23, 2019

Product – Hadlima (biosimilar, adalimumab)

  • The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy
  • The P-III clinical study resulted in bio-similarity data of Hadlima to the reference product Humira, i.e, @24 weeks ACR20 (72.4% vs 72.2%)
  • Hadlima is Samsung Bioepis’ third anti-TNF biosimilar which has received approval in the US. Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker, developed by Samsung Bioepis and will be commercialized by Merck in the US with its expected launch after Jun 30, 2019 in accordance with a licensing agreement signed with AbbVie

6.Eli Lilly’s Baqsimi (glucagon 3mg) Nasal Powder Received FDA’s Approval for the Treatment of Severe Hypoglycemia

Date – July 24, 2019

Product – Baqsimi

  • The FDA’s approval followed multiple studies with various age groups that evaluated Baqsimi (glucagon, 3mg) nasal powder vs glucagon injection formulation in patients with diabetes aged 4 years and older
  • Collective study results demonstrated non-inferiority data to glucagon injection formulation in raising blood glucose level after insulin-induced hypoglycemia, 100% patients reach treatment success i.e., increase in plasma glucose levels to ≥ 70 mg/dL or a ≥20 mg/dL rise in plasma glucose from nadir within 30 minutes post receiving glucagon
  • Baqsimi is a dry nasal spray form of glucagon, ready to use with no reconstitution or priming required in a single, fixed 3 mg dose, to be absorbed in the nose and is expected to be available within one month in the US.

7.Merck Reported Results of Keytruda (pembrolizumab) + Chemotherapy in P-III KEYNOTE-522 Study for Triple-Negative Breast Cancer  

Date – Jul 30, 2019

Product – Keytruda (pembrolizumab)

  • The P-III KEYNOTE-522 study involved assessing of Keytruda + CT vs PBO + CT as neoadjuvant therapy, followed Keytruda vs PBO as adjuvant therapy in 1,174 patients in a ratio (2:1) with TNBC
  • The P-III KEYNOTE-522 study resulted in meeting its one of the dual 1EPs i.e, improvement in pCR rates regardless of PD-L1 status, safe and tolerable, no new safety signals were observed
  • Keytruda is an anti-PD-1 therapy, blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 and activated T-lymphocytes affecting both tumor and healthy cells, being evaluated in three ongoing studies for TNBC (KEYNOTE-355, KEYNOTE-242, and KEYNOTE-522).

8.Bayer’s Vitrakvi (larotrectinib) Received Health Canada Approval for Advanced Solid Tumors Harboring NTRK Gene Fusion

Date – July 30, 2019

Product – Vitrakvi (larotrectinib)

  • Vitrakvi has received approval under Health Canada’s NOC/c policy based on the clinical study evaluating Vitrakvi in adults and children with solid tumors harboring NTRK fusion
  • The clinical study resulted in 75% ORR with 22% CR, 90% ORR is observed in children and 69% in adults. Vitrakvi therapy should be initiated following confirmation of NTRK gene fusion in a tumor specimen using a validated test
  • Vitrakvi is an oral selective TRK inhibitor act by shrinking the tumor or slowing/stopping its growth and has received FDA’s accelerated approval for solid tumors with NTRK gene fusion on Nov 26, 2018

9.Bayer’s Nubeqa (darolutamide) Received the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

Date – July 31, 2019

Product – Nubeqa (darolutamide)

  • The approval is based on P-III ARAMIS study results assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT in 1,509 in patients in a ratio (2:1) with nmCRPC. Nubeqa is approved under FDA’s PR designation and three months ahead of its PDUFA date
  • The P-III ARAMIS study resulted in meeting its 1EPs i.e, MFS (40.4 vs 18.4 months), delay in time to pain progression, time to cytotoxic chemotherapy, time to asymptomatic skeletal event demonstrated a benefit in favor of Nubeqa
  • Nubeqa is an androgen receptor inhibitor (ARi) binding it with high affinity thus inhibiting the growth of prostate cancer cells. Bayer has filed for its approval in multiple countries including the EU and Japan.

10.Voluntis’ Oleena Digital Application Received FDA’s Marketing Approval to Self-Manage Cancer Symptoms

Date – Aug 02, 2019

Product – Oleena Digital Application

  • The US FDA has completed its regulatory review of Oleena software which is a Class II medical device facilitating oncology-related symptoms management and remote patient monitoring
  • Oleena is embedded with clinical algorithms offerings real-time personalized insights and actionable recommendations to the patients for managing their own symptoms while monitoring remote patients will improve clinical outcomes and minimizes the burden on health systems
  • Voluntis’ Oleena is the first prescription digital therapeutic in oncology transforming the patient’s experience through their cancer journey and is based on a software platform, Theraxium Oncology which is designed to allow data analytics and remote maintenance of digital therapeutics.

11. AbbVie’s Maviret (glecaprevir/pibrentasvir) Received European Commission Approval for Treatment-Naive Patients with Chronic Hepatitis C and Compensated Cirrhosis

Date – Aug 02, 2019

Product – Maviret (glecaprevir/pibrentasvir)

  • The marketing authorization was based on P-IIIb EXPEDITION-8 study assessing Maviret in 280 treatment-naive chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8 weeks
  • The P-IIIb EXPEDITION-8 study resulted in @8 weeks 97.9% GT1, 2, 4, 5 & 6 patients achieved a sustained virologic response 12 weeks (SVR12); no case of virologic failures and discontinued treatment were observed
  • Maviret is a combination of NS3/4A protease & NS5A inhibitor and is an 8-week, pan-genotypic option (GT1-6) for patients who are new to treatment and without cirrhosis and for GT1, 2, 4, 5 and 6 patients who are new to treatment with compensated cirrhosis.

12.Daiichi Sankyo’s Turalio (pexidartinib) Received the US FDA’s Approval for the Symptomatic Tenosynovial Giant Cell Tumor

Date – Aug 02, 2019

Product – Turalio (pexidartinib)

  • The FDA’s approval was based on P-III ENLIVEN study results assessing Turalio vs PBO in 120 patients in ratio (1:1) with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
  • The P-III ENLIVEN study results: @25 weeks tumor response rate by RECIST v 1.1 (38% vs 0%); ORR by TVS (56% vs 0%). Turalio is approved with a boxed warning for hepatotoxicity due to the risk of liver injury
  • Turalio is the first oral therapy targeting CSF1R thus inhibiting the driver of abnormal cells in the synovium responsible for causing TGCT and has received FDA’s PR, BT, OD designation, currently under EMA’s review for TGCT.

13.Sanofi and Regeneron’s Dupixent Received European Commission Approval for Moderate-To-Severe Atopic Dermatitis in Adolescents

Date – Aug 06, 2019

Product – Dupixent (dupilumab)

  • The EC has extended the marketing authorization of Dupixent (dupilumab) to include adolescents aged 12 to 17 years. with mod. to sev. AD which was based on P-III LIBERTY AD program evaluating dupixent vs PBO
  • The P-III LIBERTY program results:  75% improvement in disease extent, Skin improvement measured by EASI-75 (42% vs 8%); clear skin (24% vs 2%); improvement in the EASI score (66% vs 24%); improvement in itch (37% vs 5%); improvement in QoL (61% vs 20%);  improvements in disease severity measured by POEM (63% vs 10%).
  • Additionally, Sanofi and Regeneron have announced results of Dupixent in P-III pediatric study assessing Dupixent + TCS vs TCS in 367 children with AD aged 6-11 years with an additional safety study evaluating Dupixent (300mg, q4w & 100/200mg, q2w) vs PBO with its expected FDA submission in Q4’19
  • The P-III pediatric study resulted in the improvement of overall disease severity, skin clearing, itching, and health-related QoL. Efficacy study results: Clear skin (33% & 30% vs 11%); skin improvement (EASI-75) (70% & 60% vs 27%); improvement in EASI score (82% & 78% vs 49%)
  • Dupixent is a mAb targeting IL-4 & IL-13 and only biologic approved in the EU for adolescent patients with mod. to sev. AD, being developed in collaboration with Regeneron.

14. Roche’s Tecentriq (atezolizumab) Received Health Canada’s Approval for 1L Extensive-Stage Small Cell Lung Cancer in Adults

Date – Aug 13, 2019

Product – Tecentriq (atezolizumab)

  • The approval was based on P-III IMpower133 study results which assessed Tecentriq + carboplatin and etoposide vs carboplatin and etoposide monothx in 403 adults with chemotherapy-naïve ES-SCLC
  • The P-III IMpower133 study results: mOS (12.3 months vs 10.3 months), mPFS (5.2 months vs 4.3 months) 30% reduction in death, OS @1 year (51.7% vs 38.2%). The regimen was included as a preferred treatment for previously untreated ES-SCLC in the 2019 NCCN Clinical Practice Guidelines in Oncology for SCLC
  • Tecentriq (atezolizumab) is a mAb targeting PD-L1 protein while blocking its interaction with PD-1 and B7.1 receptor and novel therapy approved in Canada for SCLC and is being evaluated in 12 P-III trials as monothx or in combination with other drugs.

15.Merck’s Keytruda (pembrolizumab) in Combination with Inlyta (axitinib) Received European Commission’s Approval as a 1L Therapy for Advanced Renal Cell Carcinoma

Date – Sept 04, 2019

Product – Keytruda (pembrolizumab), Inlyta (axitinib)

  • The approval was based on P-III KEYNOTE-426 study assessing Keytruda (200mg) + Inlyta (5mg) vs Sunitinib (50mg) in 861 patients in a ratio (1:1) with advanced RCC regardless of PD-L1 tumor expression and IMDC risk group
  • The P-III KEYNOTE-426 study results: improvement in OS, 47% reduction in risk of death, m-PFS (15.1 vs 11.0 months); ORR (59% vs 36%); CRR (6% vs 2%); PRR (53% vs 34%). The approval allowed marketing of Keytruda dual regimen in all 28 EU member states + Iceland, Lichtenstein, and Norway
  • KEYTRUDA is an anti-PD-1 therapy, which acts by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 thus activates T lymphocytes which affects both tumor and healthy cells and was the first anti-PD-1 therapy to be approved in EU as combination therapy for RCC across all IMDC risk groups.

16.Baxter Acquired Cheetah Medical for ~$230M

Date – Sept 10, 2019

Deal Value – $230M

  • Baxter acquired Cheetah Medical for up to $230M including $190M as upfront with $40M as clinical & development milestones
  • The acquisition was expected to close in Q4’19. The focus of the acquisition was to expand Baxter’s specialized patient monitoring portfolio with the addition of Cheetah’s non-invasive hemodynamic monitoring technologies which included Starling SV system used for fluid management and enhanced Baxter’s leadership in medication delivery and critical care
  • Cheetah’s acquisition supported Baxter’s efforts to enable personalized therapy and help to eliminate preventable harm across the globe. Cheetah’s technologies are designed to be used in an operating room and emergency department settings providing assessments of fluid responsiveness.

17. Teva Canada’s Herzuma (biosimilar, trastuzumab) Received Health Canada Approval for Multiple Cancer Indications

Date – Sept 11, 2019

Product – Herzuma (biosimilar, trastuzumab)

  • Health Canada granted notice of compliance for Teva Canada’s Herzuma for the treatment of early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) in Canada
  • The Health Canada NOC was based on efficacy, safety, quality, immunogenicity, PK/PD data from non-clinical and clinical studies, which demonstrated that Herzuma and Herceptin had high bio similarity in terms of purity, potency and safety for the three approved indications
  • Herzuma is a mAb biosimilar of the reference product, Herceptin targeting ECD of HER2 receptor and received MFDS, EC and the FDA’s approval in Jan’2014, Feb’2018 and Dec’2018 respectively.

18. Lundbeck Acquired Alder Biopharmaceuticals for $1.95B 

Date – Sept 16, 2019

Deal Value – $1.95B

  • Lundbeck acquired Alder Biopharmaceuticals in the all-cash transaction which made a total deal value $1.95B. Alder received $18/share as an upfront, non-tradeable CVR of $2/share on EMA’s approval of Eptinezumab with 79% premium to Alder’s shareholders based on the closing price on Sept 13, 2019
  • The transaction was expected to close in Q4’19. The focus of the acquisition was to enhance Lunbeck’s neurology portfolio with the expected US launch of Alder’s Eptinezumab (IV) for the prevention of episodic and chronic migraine in 2020 and gain access to Alder’s mAb expertise with the addition of its ALD1910, an early stage Ab
  • Eptinezumab is an investigational mAb, administered as a quarterly 30-minute IV infusion with its expected BLA submission in Feb’2019 and PDUFA date as Feb 21, 2020 and anticipated regulatory submission to EMA in 2020 following submission in other regions including China & Japan

19. Bayer Signed a License Agreement with Informed Data Systems to Utilize its One Drop Digital Therapeutics Platform

Date – Sept 17, 2019

Deal Value – $10M

  • Bayer invested $20M in Series B financing and provided an upfront of $10M to Informed Data System for developing and commercializing the One Drop technology platform
  • The collaboration allowed Bayer to access One Drop self-care platform for managing across multiple therapeutic areas with strong AI capabilities leading to better healthcare outcomes for patients with chronic conditions and support Bayer’s Integrated Care patient services offerings
  • One Drop is an evidence-based, innovative digital therapeutic platform utilizing an integrated patient-facing application, monitor and coaching/behavioral change programs and brings affordable accessible diabetes care to patients with diabetes

20. Astellas and FibroGen’s Evrenzo (roxadustat) Received MHLW’s Approval for Anemia Associated with Chronic Kidney Disease in Dialysis Patients

Date – Sept 20, 2019

Product – Evrenzo (roxadustat)

  • The approval was based on four P-III studies evaluating Evrenzo (20/50/100mg) in CKD anemic patients on dialysis in Japan, which demonstrated an increment in the hemoglobin level and was well tolerated among the patients, marking the first approval of the collaboration
  • Astellas and FibroGen collaborated to develop Evrenzo for treating anemia in Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa while FibroGen collaborated with AstraZeneca for Evrenzo in the US, China & other markets
  • Evrenzo (PO) is a HIF-PH inhibitor, approved for anemia associated with CKD in both dialysis-dependent and non-dialysis-dependent patients with anticipates approval in the US & EU.

21. AstraZeneca’s Qtrilmet Received CHMP’s Recommendation for its Approval to Treat Patients with Type-2 Diabetes in Europe

Date – Sept 23, 2019

Products – Qtrilmet, Forxiga (dapagliflozin), Onglyza (saxagliptin),

  • The CHMP’s positive opinion was based on five P-III studies assessing Forxiga (dapagliflozin) + Onglyza (saxagliptin) + Metformin vs the Forxiga + Metformin/Onglyza + Metformin/Glimepiride/Metformin in patients with inadequately controlled T2D
  • The P-III study results demonstrated that Qtrilmet resulted in a reduction of HbA1c and was not inferior to the combined use of insulin and metformin with or without SU in reducing HbA1c
  • Qtrilmet is a combination of SGLT2 inhibitor, DPP‑4 inhibitor & metformin hydrochloride extended-release and was approved under the name Qternmet XR as an adjunct to diet and exercise to improve glycemic control in adults with T2D in the US.

22. Bayer’s Vitrakvi (larotrectinib) Received EMA’s Approval as the First Tumor Agonist in Europe

Date – Sept 23, 2019

Product – Vitrakvi (larotrectinib)

  • The approval was based on the pooled clinical study including P-I study in adults, P-II NAVIGATE study in adults & adolescents & P-I/II pediatric SCOUT study which assessed Vitrakvi in 102 patients (93 patients from the primary analysis population and an additional 9 patients with primary CNS tumors) with solid tumors which displayed NTRK gene
  • Results: primary analysis population, ORR (72%); CR (16%); PR (55%); Post 1yr. 88% patients were alive; primary CNS patients, ORR (67%); CR & PR (15% & 15%); neither mDOR nor mPFS met at the time of analysis
  • Vitrakvi is an oral highly selective TRK inhibitor, already approved in the US, Brazil & Canada. Following LOXO acquisition, Bayer got WW exclusive licensing right to develop & commercialize larotrectinib and the investigational TRK inhibitor BAY 2731954.

23. Biocon Biologics Acquired Pfizer’s Research Facility to Expand its Research and Development Footprint

Date – Sept 24, 2019

Deal Value – Biosimilars

  • Biocon Biologics acquired Pfizer’s 60,000 sq. ft state-of-the-art, bench to pilot scale R&D facility at TICEL Bio Park in Chennai, India
  • The focus of the acquisition was to expand Biocon’s R&D capabilities and to accelerate the development of its biosimilars from lab to pilot scale, which addressed the needs of patients globally
  • The facility housed an early stage R&D center including pilot-scale R&D unit, equipped with cell line development, drug substance process development from bench scale to 400L scale bioreactors, drug product formulation laboratories, analytical R&D laboratories with 250+ scientists.

24. Amgen Acquired Celgene’s Otezla (apremilast) for $13.4B 

Date – Sept 26, 2019

Deal Value – $13.4B

  • Amgen acquired Otezla for $13.4B in cash and received its related intellectual property including patents who primarily covered apremilast with all assets and liabilities related to Otezla along with Celgene’s employees associated with the Otezla
  • BMS divested Otezla in order to get regulatory approval for its pending Celgene merger. The closing of the acquisition of Otezla is contingent on FTC’s blessing on the BMS & Celgene’s pending merger, its closing and the satisfaction of other closing conditions. BMS is completed its pending merger in H2’19
  • Otezla is a selective PDE4 inhibitor, inhibiting the production of TNF-alpha from human rheumatoid synovial cells and an approved therapy for mod. to sev. plaque psoriasis for whom phototherapy or systemic therapy was appropriate.

25. Everyday Health Group Acquired Johnson and Johnson’s BabyCenter a Global Digital Pregnancy and Parenting Resource

Date – Sept 27, 2019

Product – Johnson and Johnson’s BabyCenter

  • Everyday Health acquired BabyCenter combining it’s “What to Expect” digital pregnancy and parenting platform, with the focus of supporting parents through the journey of pregnancy and early parenting plus combined expertise for engaging digital experiences of parenthood
  • What to Expect is Everyday Health’s first rated digital pregnancy app in the Apple Store, awarded under the Lifestyle category for its Pregnancy Due Date Calculator in 2019 Webby Award
  • BabyCenter works globally with 100M+ people monthly, with 7 in 10 new and expectant moms using multiple digital platforms in the US and operates 10 international versions in 9 different languages along with multiple international app editions

26. Sobi Acquired Dova Pharmaceuticals for $915M

Date – Sept 30, 2019

Deal Value – $915M

  • Sobi acquired Dova Pharmaceutical who’s in cash & stock transaction made a total deal value of $915M.  Dova received upfront of $27.50/share in cash, $1.50/share on approval of Doptelet as CVR, which represented a total consideration of up to $29.00/share with a premium of 36% to Dova’s closing price on Sept 27, 2019
  • The focus of the acquisition was to bolster Sobi’s hematology & orphan diseases portfolio with the addition of Dova’s Doptelet and expand its presence in the US. The transaction was expected to be completed in Q4’19
  • Dova’s Doptelet (avatrombopag) is a second-generation small molecule thrombopoietin receptor (TPO) agonist, act by increasing platelet count to treat thrombocytopenia, currently being evaluated in P-III study for chemotherapy-induced thrombocytopenia (CIT) and received FDA’s approval for CLD & ITP in May’2018 & Jun’2019 respectively.

27. GSK’s Nucala (mepolizumab) Received the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11 years

Date – Sept 30, 2019

Product – Nucala (mepolizumab)

  • The US FDA’s approval followed the open-label study which evaluated PK/PD and long-term safety of Nucala (40mg, SC) in children with severe eosinophilic asthma aged 6 to 11 years
  • The approval was also supported by results of well-controlled studies assessing Nucala in adults and adolescents. The 52 weeks long term study of Nucala in pediatric patients aged 6-11 years was similar to a safety profile in patients aged ≥12 years
  • Nucala (100mg, SC) is mAb targeting IL-5, approved as an add-on maintenance therapy for severe eosinophilic asthma patients aged ≥12 years in 2015. In Aug 2018, Nucala received approval as an add-on treatment for severe eosinophilic asthma in patients aged 6-11years in the EU.