Insights+ Exclusive: Novel Approvals of February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan 2020. Last year in 2019, the US FDA has approved 48 novel products. Pharmashots has compiled a list of 10 new drugs approved by the US FDA in February 2020.

1. Agile Therapeutics Received the US FDA’s Approval for Twirla (levonorgestrel and ethinyl estradiol) Transdermal System

Published: Feb 14, 2020 | Tags: Agile Therapeutics, Approval, Ethinyl Estradiol, The US FDA, Levonorgestrel, Received, Transdermal, System, Twirla

  • The US FDA approved Agile’s non-daily, non-invasive contraceptive, Twirla for contraception in women with BMI is <30 kg/m2 and for whom a combined hormonal contraceptive is appropriate
  • The transdermal system must be applied weekly to the abdomen, buttock, or upper torso (Ex- breast) to deliver a 30mcg daily dose of ethinyl estradiol and 120mcg daily dose of levonorgestrel
  • The approval needed the company to conduct a post-marketing study to assess risks for venous thromboembolism and arterial thromboembolism in new users of the contraception compared with new users of other combined hormonal contraceptives

2. Horizon’s Procysbi (Cysteamine Bitartrate) Received the US FDA’s Approval for Delayed Release Oral Tablets

Published: Feb 18, 2020 | Tags: Approval, Cysteamine Bitartrate, Delayed, Horizon, Oral, tablets, Procysbi, Received, Release, The US FDA

  • The US FDA approved Procysbi for adults and children one year of age and older living with nephropathic cystinosis
  • Procysbi (cysteamine bitartrate) is delayed-release capsules and delayed-release oral granules also a cystine-depleting agent indicated to treat nephropathic cystinosis in adults and pediatric patients 1 year of age and older
  • Procysbi will be available in 25 mg and 75 mg strengths while the 75 mg and 300 mg is expected to be available in H1’20

3. Eagle’s Pemfexy (pemetrexed for injection) Received the US FDA’s Approval to Treat Nonsquamous Non-Small Cell Lung Cancer

Published: Feb 11, 2020 | Tags: Approval, Eagle, FDA, Nonsquamous, Non-Small Cell Lung Cancer, Pemetrexed, Injection, Pemfexy, Receives

  • The US FDA approved Eagle’s Pemfexy, a branded alternative to Alimta and is expected to be available in the market from Feb 01, 2022 with a subsequent uncapped entry on Apr 01, 2022
  • The Pemfexy has received its tentative approval in 2017, indicating that therapy met all its quality, safety and efficacy standards, but at the time was not eligible for marketing in the US because of existing patent protections
  • The final approval follows the settlement agreement signed b/w Eagle and Eli Lilly on Dec 13, 2019, providing a release from all claims by the parties. Following the final approval, Eagle has exclusive rights to commercialize Pemfexy (ready to dilute formulation) for 4mos. beginning Feb 01, 2022

4. Esperion’s Nexletol (bempedoic acid) Tablet Received the US FDA’s Approval for Lowering Cholesterol Level

Published: Feb 24, 2020 | Tags: Approval, Bempedoic Acid, Cholesterol Level, Esperion, Lowering, Nexletol, Received, Tablet, The US FDA 

  • The approval was based on P-III global pivotal P-III LDL-C lowering program assessing NEXLETOL vs PBO in 3000+ patients corrected LDL-C lowering when used with moderate or high-intensity statins., NEJM
  • The study resulted in well-tolerated results, providing an average of 18% PBO corrected LDL-C lowering when used with moderate or high-intensity statins
  • NEXLETOL is a novel orally administered once-daily ATP Citrate Lyase (ACL) inhibitor involved in lowering LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors

5. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Received the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

Published: Feb 26, 2020 | Tags: Approval, Bempedoic Acid Esperion Ezetimibe, LDL-Cholesterol Lowering, Medicine, Nexlizet, Received, Tablet, The US FDA

  • The approval was based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
  • The study resulted in well-tolerated data and lowered LDL-C by 38% when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
  • Nexlizet is an oral QD, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul, 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

6. Baudax Bio’s Anjeso Received the US FDA’s Approval to Manage Moderate to Severe Pain

Published: Feb 27, 2020 | Tags: Adults, Approval, Biohaven, Migraine, Nurtec, Received, The US FDA, Treatment

  • The approval of Anjeso was based on two P-III studies assessed Anjeso (30mg, bolus injection) following Major Surgery and Abdominoplasty Surgery vs PBO in the ratio (1:1) in 932 patients
  • The study demonstrated well-tolerated results, also achieved 15 of the 19 secondary endpoints, plus statistically significant differences in SPID6, SPID12, SPID24, SPID24-48 with no serious adverse events
  • Anjeso (meloxicam) injection is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities also approved by the US FDA in Feb, 2020 for moderate to severe pain, alone or in combination with other non-NSAID analgesics

7. Biohaven’s Nurtec Received the US FDA’s Approval for Treatment of Migraine in Adults

Published: Feb 27, 2020 |Tags: Adults, Approval, Biohaven, Migraine, Nurtec, Received, The US FDA, Treatment

  • The approval is based on P-III study (Study 303) and Study 201 which involves assessing of Nurtec vs PBO in patients with migraine
  • The study resulted in well-tolerated results. Additionally, Biohaven launched a broad suite
  • Nurtec (rimegepant, 75mg) is a first and only calcitonin gene-related peptide (CGRP) receptor antagonist approved by the US FDA to treat migraine in adults

8. Acacia’s Barhemsys (amisulpride) Received the US FDA’s Approval for the Prevention of Postoperative Nausea and Vomiting

Published: Feb 28, 2020 |Tags: Acacia, Amisulpride, Approval, Barhemsys, Postoperative Nausea, Prevention, Receives, The US FDA, Vomiting

  • Barhemsys is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed standard prophylaxis with its anticipated launch in H2’20
  • The results of the clinical program showed that Barhemsys (10mg) was significantly more effective vs PBO (42% vs 29%) while in another study Barhemsys (5mg) + other antiemetics vs PBO demonstrated improvement in protection from PONV (58% vs 47%)
  • Barhemsys is an IV formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL). Additionally, Acacia’s Byfavo (remimazolam injection) is currently under FDA’s review for use in procedural sedation in an adult with its anticipated PDUFA as Apr 05, 2020

9. Lundbeck’s Vyepti (eptinezumab-jjmr) Received the US FDA’s Approval to Prevent Migraine in Adults

Published: Feb 28, 2020 | Tags: Adults, Approval, Eptinezumab-Jjmr, Lundbeck, Migraine, Prevent, Received, The US FDA, Vyepti

  • The approval was based on two P-IIItrials PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine involves assessing of Vyepti (100mg or 300mg) vs PBO in 2076 patients with migraine
  • PROMISE 1 study results: mean migraine frequency ~8.6 migraine days/month, mean change in MMD in 1-3mos. @100mg or 300mg  (-3.9 days, -4.3 days vs -3.2 days), Responders with at least 50% & 75% reduction in MMD in 1-3mos. (49.8% & 22.2%, 56.3% & 29.7% vs 37.4%, 16.2%), greater patients had migraine @first 7 days vs PBO
  • PROMISE 2 study: Mean migraine frequency ~ 16.1 migraine days/month, the mean change in MMD in 1-3mos. @100mg or 300mg (-7.7 days, -8.2 days vs -5.6 days), Responders with at least 50% & 75% reduction in MMD in 1-3 mos. (57.6% & 26.7%, 61.4% & 33.1% vs 39.3%, 15.0%)
  • Vyepti is mAb that binds to calcitonin gene-related peptide (CGRP) ligand further blocking the binding to receptors. The company has also submitted marketing application in Canada with expected submission to the EU in 2020

10. GSK’s Advil Dual Action in Combination with Acetaminophen Received the US FDA’s Approval for Pain Relief 

Published: Feb 28, 2020 | Tags: Acetaminophen, Received, Advil Dual Action, Approval, Combination, GSK, Pain Relief, The US FDA

  • The approval was based on seven clinical studies including three of which were pivotal efficacy and safety studies in pain relief which involves assessing of ibuprofen (250 mg) + acetaminophen (500 mg) vs ibuprofen and acetaminophen monothx in patients with acute pain symptoms
  • The study demonstrated that the FD combination achieved superior efficacy than the monotherapy in patients
  • Advil Dual Action is combination of ibuprofen and acetaminophen resulting in an exclusive pain reliever and will be available over-the-counter nationwide in 2020