Allergan plc AGN announced that the FDA has accepted its new drug application (“NDA”) for oral anti-calcitonin gene-related peptide (“CGRP”) candidate, ubrogepant. The NDA is seeking approval of the candidate as an acute treatment for migraine in adult patients. A decision from the FDA is expected in the next 10 months or the fourth quarter of 2019.
Ubrogepant will be the first orally administered anti-CGRP drug available for treating migraine, if approved, in the United States.
Allergan’s shares have increased 9.7% this year so far compared with the industry’s rise of 7.2%.
The NDA 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 two pivotal studies, evaluating it for the treatment of single migraine attack.
Data from the studies also demonstrated that ubrogepant was able to treat migraine patients who have insufficient response or are ineligible for treatment with a 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.
Meanwhile, the company has another oral anti-CGRP candidate, atogepant, in its pipeline that demonstrated positive results in a phase II study, evaluating it for the treatment of episodic migraine attack.
Allergan’s largest product, Botox, is approved for treating migraine among several other indications. However, the competition in the anti-CGRP segment is strong. In 2018, three anti-CGRP drugs received approval from the FDA for treating migraine – Amgen/Novartis’ NVS Aimovig, Eli Lilly’s LLY Emgality and Teva Pharma’s TEVA Ajovy. However, oral administration may help ubrogepant to gain strong adoption compared to the other anti-CGRP drugs, which are approved as injections.
Allergan has more than 65 projects in mid-to-late stage development including six key programs including 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 opportunity.
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 have an unfavorable impact on revenues. Hence, successful development of pipeline candidates is necessary for the company to offset branded/generic competition.
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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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