Allergan plc AGN announced that the FDA approved a new drug application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Ubrelvy is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks. It has been approved in two dose strengths — 50 mg and 100 mg.
Migraine is a neurological disease with episodic attacks defined by symptoms such as headache, sensitivity to light and sound, and nausea. With just one dose, this drug can quickly eliminate patients' migraine pain and symptoms compared with placebo at two hours.
The approval was supported by data from two pivotal phase III studies — ACHIEVE I & II — and two additional safety studies evaluating ubrogepant. The candidate demonstrated positive results in both pivotal studies, which evaluated it for the treatment of a single migraine attack.
Data from the additional safety studies demonstrated that ubrogepant was able to treat migraine patients who have an insufficient response to or are ineligible for treatment with triptan, one of the commonly used medications for migraine. Migraine patients with moderate-to-severe cardiovascular risk will also be eligible for treatment with ubrogepant.
The NDA for ubrogepant was accepted for review by the FDA in March. The FDA granted the application a normal review period of 10 months.
Shares of the company have surged 43.3% year to date compared with the industry’s growth of 8.8%.
Meanwhile, the company has another oral anti-CGRP candidate, atogepant, in its pipeline that demonstrated positive results in a phase II study, which evaluated it for the treatment of episodic migraine attack.
Allergan’s largest product, Botox, is also approved for treating migraine, among several other indications. However, the competition in the anti-CGRP segment is strong. In 2018, three anti-CGRP drugs — Amgen/Novartis’ NVS Aimovig, Eli Lilly’s LLY Emgality and Teva Pharma’s TEVA Ajovy — received approval from the FDA for treating migraine. However, oral administration may help ubrogepant gain strong adoption compared to the other anti-CGRP drugs, which are approved as injections.
Allergan has more than 46 projects in mid-to-late-stage development, including six key programs on ubrogepant and atogepant for migraine, Abicipar for age-related macular degeneration ("AMD"), label expansion of Vraylar (cariprazine) for bipolar depression, and Bimatoprost SR for glaucoma. The company’s biosimilar pipeline also provides significant growth opportunities.
However, the company is facing loss of exclusivity for many blockbuster products. Rising generic competition and anticipated branded competition for key drugs are likely to negatively impact revenues. Hence, the successful development of the pipeline candidates is necessary for the company to offset such competition.
Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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