February 2020 decisions expected from the FDA

2/1/2020: rimegepant Zydis® orally dissolving tablet (ODT) and tablet

The U.S. Food and Drug Administration (FDA) is reviewing Biohaven’s two applications for rimegepant ODT and tablet formation for acute treatment of migraines. Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. Biohaven demonstrated the safety and efficacy of rimegepant compared to placebo in three completed Phase 3 trials and a Phase 2b trial. Rimegepant met primary and secondary endpoints of relief from migraine pain and the most bothersome migraine-associated symptom compared with placebo.1 Biohaven is enrolling patients in a Phase 2 proof of concept trial. This will evaluate the safety and efficacy of rimegepant in patients with treatment-refractory trigeminal neuralgia.2 Similar products include Allergan’s Ubrelvy® (ubrogepant).

2/4/2020: empagliflozin, linagliptin and metformin XR

The FDA is reviewing Boehringer Ingelheim and Eli Lilly’s New Drug Application (NDA) for the triple combination tablet of empagliflozin, linagliptin and metformin extended release for the treatment of type 2 diabetes in adults. Boehringer Ingelheim submitted clinical data from two randomized, open-label trials that found bioequivalence of empagliflozin, linagliptin and metformin XR combination tablets and their individual components in healthy adults.3 Similar products include Boehringer Ingelheim’s Glyxambi® (empagliflozin/linagliptin) tablet, Boehringer Ingelheim’s Jardiance® (empagliflozin) and Boehringer Ingelheim’s Tradjenta® (linagliptin).

2/16/2020: Twirla™ (ethinyl estradiol and levonorgestrel transdermal system)

Agile Therapeutics’s Twirla is being reviewed by the FDA as a low dose contraceptive patch. The patch is intended to optimize patch adhesion and patient wearablity. Agile Therapeutics conducted a comparative wear study. The primary endpoint for the study was the mean difference in adhesion scores between Twirla and Mylan’s Xulane® (ethinyl estradiol and norelgestromin), the generic version of Ortho Evra®. No complete detachments of Twirla or Xulane occurred during the trial. Twirla demonstrated non-inferior adhesion to Xulane. In October 2019, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) met to discuss Twirla. At the FDA’s request, Agile Therapeutics provided the FDA with additional information. The FDA then extended the PDUFA date from November 2019 to February 2020.4

2/21/2020: bempedoic acid

Esperion Therapeutics’ bempedoic acid is being reviewed by the FDA for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies. Bempedoic acid is a non-statin oral once daily tablet. It is a first-in-class medication that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Completed Phase 3 studies demonstrated a significant reduction in LDL-C lowering compared to placebo in patients with or without concurrent use of statins.5 Esperion has initiated a global cardiovascular outcome trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk of, cardiovascular disease who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered statin averse.5 The CVOT, CLEAR, completed its enrollment August 2019. Similar products include Regeneron’s Praluent® (alirocumab) injection, and Amgen’s Repatha® (evolocumab) injection.

2/26/2020: bempedoic acid / ezetimibe

Esperion Therapeutics’ bempedoic acid/ezetimibe combination product is being reviewed by the FDA for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies. Bempedoic acid / ezetimibe is a fixed dose tablet (180mg/10mg). Phase 3 data demonstrated that this combination tablet had a greater decrease in LDL-C and C-reactive protein (hsCRP) when compared with placebo.6 Similar products include Regeneron’s Praluent® (alirocumab), Amgen’s Repatha® (evolocumab), and Merck’s Zetia® (ezetimibe).

2/22/2020: eptinezumab

The FDA is reviewing Adler BioPharmaceuticals’ eptinezumab for migraine prevention. Eptinezumab is a monoclonal antibody, administered intravenously, targeting calcitonin gene-related peptide (CGRP). Adler BioPharmaceuticals published two Phase 3 clinical trials comparing eptinezumab to placebo. Both PROMISE 1 and PROMISE 2 met primary and secondary endpoints of decreasing monthly migraines over a 12-week treatment period.7 Similar products, all of which are available as subcutaneous injections, include Novartis’ Aimovig® (erenumab-aooe), Eli Lilly’s Emgality® (galcanezumab-gnlm), and Teva’s Ajovy® (fremanezumab-vfrm).

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References

1. https://www.prnewswire.com/news-releases/biohavens-positive-phase-3-trial-of-rimegepant-zydis-orally-dissolving-tablet-for-acute-treatment-of-migraine-published-in-the-lancet-300884415.html
2. https://www.sec.gov/Archives/edgar/data/1689813/000168981319000055/a2019q2bhvnearningspre.htmhttps://www.empr.com/home/news/drugs-in-the-pipeline/fda-to-review-triple-combination-tablet-for-type-2-diabetes/
3. https://www.globenewswire.com/news-release/2019/11/14/1947637/0/en/Agile-Therapeutics-Announces-FDA-Extension-of-Twirla-NDA-Review-Period.html
4. https://www.globenewswire.com/news-release/2019/10/25/1935745/0/en/Bempedoic-Acid-Included-in-Top-10-Medical-Innovations-for-2020-List.html
5. https://www.businesswire.com/news/home/20191117005069/en/Bempedoic-Acid-Lowers-LDL-Cholesterol-Adversely-Impacting-Glycaemichttps://investor.alderbio.com/news-releases/news-release-details/us-food-and-drug-administration-accepts-biologics-license