Insights+: EMA Marketing Authorization of New Drugs in January 2023

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Insights+: EMA Marketing Authorization of New Drugs in January 2023


  • The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry
  • In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis
  • PharmaShots has compiled a list of a total of 8 new drugs approved by the EMA in January 2023

Gilead Reports EMA's Validation of MAA for Trodelvy (sacituzumab govitecan-hziy) to Treat HR+/HER2- Metastatic Breast Cancer


Active ingredient: sacituzumab govitecan-hziy                      Approved: January 03, 2023

Company: Gilead                                                                       Disease: Breast Cancer

  • The EMA has validated a Type II variation MAA for Trodelvy to treat adult patients with unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy & 2 additional systemic therapies in the metastatic setting
  • The MAA was based on the P-III study (TROPiCS-02) evaluating Trodelvy vs CT (eribulin, capecitabine, gemcitabine, or vinorelbine) in a ratio (1:1) in 543 patients. The trial met its 1EPs of PFS & 2EPs of OS. The PFS data were published in the Journal of Clinical Oncology & OS data were presented at ESMO 2022
  • The safety profile was consistent with prior studies with no new safety signals. The US FDA has accepted the sBLA of Trodelvy for priority review in Oct 2022 & the PDUFA date is Feb 2023

Roche’s Xofluza (baloxavir marboxil) Receives EC’s Approval for the Treatment of Influenza in Children Aged ≥1 Year


Active ingredient: baloxavir marboxil                                       Approved: January 12, 2023

Company: Roche                                                                        Disease: Influenza

  • Xofluza has been approved by the EC for use in children aged ≥1yr. for uncomplicated influenza & post-exposure prophylaxis of influenza
  • The approval was based on the P-III study (miniSTONE-2) & (BLOCKSTONE) evaluating single-dose of Xofluza. The study (miniSTONE-2) met its 1EPs of safety & showed a reduction in the length of time that influenza was released from the body by ≥2 days vs oseltamivir (median time of 24.2 vs 75.8hrs.), was well tolerated with no new safety signals
  • In the (BLOCKSTONE) study, significant prophylactic effects were observed after a single oral dose by lowering the risk of individuals after exposure to an infected household member (1.9% in Xofluza vs 13.6% in PBO). Xofluza has approved in 70+ countries for influenza types A & B

AstraZeneca’s Tezspire (tezepelumab) Receives the EU Approval for the Treatment of Severe Asthma


Active ingredient: tezepelumab                                       Approved: January 13, 2023

Company: AstraZeneca                                                    Disease: Asthma

  • The EMA’s CHMP issued a positive opinion on Tezspire (tezepelumab) for self-administration in a pre-filled, single-use pen for patients aged ≥12yrs. with sev. asthma
  • The approval was based on the (PATHFINDER) program incl. results from the P-I trial (PATH-BRIDGE) & P-III trial (PATH-HOME) evaluating Tezspire (210mg). In the (PATH-HOME) trial, 92% of healthcare providers, patients, and caregivers were able to successfully administer Tezspire in the clinic & home along with an improvement in asthma control & safety profile was consistent with prior trials
  • The US FDA’s decision on self-administration and the new pre-filled pen is expected in H1’23. The therapy was approved in the US, EU, Japan & other countries for the treatment of sev. asthma

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU Approval as First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer


Active ingredient: trastuzumab deruxtecan                                   Approved: January 26, 2023

Company: Daiichi Sankyo and AstraZeneca                                  Disease: Breast Cancer

  • The EC has approved Enhertu (HER2-directed ADC) as monotx. for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who received prior CT in the metastatic setting or developed disease recurrence during or within 6mos. of completing adjuvant CT
  • The approval was based on the P-III trial (DESTINY-Breast04) evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients at multiple sites in Asia, EU & North America, showed a 50% reduction in risk of disease progression or death, m-PFS (9.9 vs 5.1mos.), 36% reduction in risk of death with m-OS (23.4 vs 16.8mos.)
  • The safety profile was consistent with prior trials with no new safety concerns. Enhertu (6.4mg/kg) was approved in 30+ countries for HER2+ gastric or GEJ adenocarcinoma

BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Sotyktu (deucravacitinib) for Plaque Psoriasis


Active ingredient: deucravacitinib                                       Approved: January 27, 2023

Company: BMS                                                                         Disease: Plaque Psoriasis

  • The opinion was based on the P-III trials (POETYK PSO-1 & 2) results evaluating the safety & efficacy of Sotyktu (6mg, qd) vs PBO and Otezla (30mg, BID) in 666 & 1020 patients along with an additional 2yr. results from the (POETYK PSO) long-term extension trial
  • The results showed significant & clinical improvements in skin clearance, symptom burden & QoL. The therapy was well-tolerated with a low rate of discontinuation due to AEs & both trials results were published in the JAAD
  • Sotyktu was approved in the US for adults with mod. to sev. PsO in Sept 2022, and in Japan for PsO, GPP & erythrodermic psoriasis in Sept 2022. The therapy is currently under regulatory review by other health authorities globally

Pfizer Receives EMA’s CHMP Positive Opinion of Paxlovid for COVID-19


Active ingredient: nirmatrelvir and ritonavir                             Approved: January 27, 2023

Company: Pfizer                                                                           Disease: COVID-19

  • The EMA’s CHMP issued a positive opinion recommending the conversion of cMA for Paxlovid (SARS-CoV-2 Mpro inhibitor) to full MA for adults with COVID-19 who do not require supplemental oxygen & are at increased risk of the disease becoming severe. The EC’s final decision is expected shortly
  • The recommendation was based on the totality of efficacy, safety & quality data. Paxlovid's advantages in assisting in lowering sev. COVID-19-related outcomes, such as hospitalization and death in high-risk patients continue to outweigh its potential risks
  • Paxlovid was approved or authorized for conditional or emergency use in 70+ countries. It is generally administered at 300mg (two 150 mg tablets) of nirmatrelvir with one 100mg of ritonavir, BID for 5 days

Regeneron Receives EMA’s CHMP Positive Opinion Recommending Expanded Approval of Dupixent (dupilumab) for Atopic Dermatitis


Active ingredient: dupilumab                                               Approved: January 27, 2023

Company: Regeneron                                                           Disease: Atopic Dermatitis

  • The EMA’s CHMP has adopted a positive opinion recommending expanded approval for Dupixent to treat sev. AD. The EC’s final decision is expected in the coming months
  • The opinion was based on the P-III trial results evaluating Dupixent (200/300mg, q4w) added to SoC low-potency TCS vs low-potency TCS alone in 162 children aged 6mos. to 5yrs.
  • The trial met all 1EPs & 2EPs i.e., Dupixent + low-potency TCS showed improvement in skin clearance & reduced overall disease severity @16wks., reduction in itch & skin pain along with improved sleep quality & health-related QoL while the Long-term data showed a sustained improvement in the disease measures @~1yr. & the safety results were consistent with the known safety profile of Dupixent

Regeneron and Sanofi Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Eosinophilic Esophagitis


Active ingredient: dupilumab                                                  Approved: January 30, 2023

Company: Regeneron and Sanofi                                           Disease: Eosinophilic Esophagitis

  • The EC has expanded the marketing authorization for Dupixent in adults & adolescents aged ≥12yrs. The EC’s decision was based on the 52wk. results from a P-III trial consisting of 3 parts i.e., parts A, B, C (n=42, 79, 188) evaluating Dupixent (300mg, qw) vs PBO for 24wks.
  • The part A & B results showed ~10 times higher rate of histological remission (60% & 59% vs 5% & 6%); reduction in disease symptoms (69% & 64% vs 32% & 41%), clinical improvement (21.9 & 23.8-point vs 9.6 & 13.9-point)
  • ≥7-fold reduction in abnormal endoscopic (-3.2 & -4.5 points vs -0.3 & -0.6 points), improvement in swallowing-related pain & health-related QoL & less frequent non-swallowing symptoms while long term efficacy in part C was similar to parts A & B results

Note: Sotyktu, Paxlovid & Dupixent received EMA’s CHMP Positive Opinion and EMA's Validation of MAA for Trodelvy

Related Post: Insights+: EMA Marketing Authorization of New Drugs in December 2022

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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