Dive Brief:
- Allergan aims to submit its acute migraine therapy ubrogepant to the Food and Drug Administration early next year, confident in the drug's profile after positive results from two safety studies announced Wednesday.
- If approved, ubrogepant would join a market made newly competitive by the recent approval of three preventive biologic drugs that block a protein called CGRP. While Allergan's therapy inhibits the same pathway, it's an oral treatment and is designed to treat migraines after they develop.
- Data from the two safety and tolerability studies, as well previously reported efficacy data, will support ubrogepant's application. Allergan reported no signs of drug-induced liver injury or hepatic safety concerns in either study.
Dive Insight:
Amgen and Novartis' Aimovig (erenumab), approved in May and launched in August, was the first of anti-CGRP drug to hit the market for migraine. Aimovig is an injectable and approved as a preventive, and has since been joined by Teva's Ajovy (fremanezumab) and Eli Lilly's Emgality (galcanezumab). Alder Biopharmaceuticals is trying to catch up, with its drug eptinezumab in Phase 3 testing.
Ubrogepant, by contrast, is dosed orally, and is given as an acute treatment for migraines as they happen.
Previous work with small molecule CGRP inhibitors ran into liver toxicity that led Merck & Co. to shutter development of a drug called telcagepant.
"The potential for liver toxicity has been a key debate regarding Allergan’s oral CGRP compound ubrogepant, for the acute treatment of migraine headaches," said Vamil Divan, an analyst at Credit Suisse, in an Oct. 17 note. "We think this update is encouraging and should help mitigate some investor concerns around the safety of the product."
Divan did, however, raise the point that there were no specific details on the actual number of events mentioned in the company's press release, leaving investors with some questions until presentation of the full data.
Allergan already has a presence in migraine, with its multipurpose injectable Botox (onabotulinumtoxin A) approved for chronic migraine since 2010. The pharma is also developing a preventive oral CGRP inhibitor called atogepant.