The way is clear for Allergan to file one of its most valuable pipeline projects, the acute migraine candidate ubrogepant, after laying to rest liver safety fears. Allergan reported data from two safety trials of the project for episodic migraine, for which the company said “no signal of drug-induced liver injury or hepatic safety concern was observed”. The first study was a long-term safety extension in 1,254 patients who participated in the pivotal Achieve I and II trials; the second was an eight-week trial in 516 healthy subjects who alternated two days of 100mg ubrogepant treatment with two days of placebo, to replicate usual treatment patterns. To be clear of a liver safety signal is an important step towards approval, given that similar CGRP inhibitor projects like Merck & Co’s telcagepant were discontinued after researchers detected liver enzyme elevations. Allergan said it would submit ubrogepant for approval in the first quarter of 2019; the project is expected to bring in sales of $454m by 2024, according to EvaluatePharma consensus. Its closest competitor, Biohaven Pharmaceutical’s rimegepant, is due to yield key safety data by the end of 2019. Both agents are expected to treat acute migraines, in contrast with marketed drugs like Aimovig, which are preventive treatments.
|Outlook for oral-CGRP inhibitors in migraine|
|WW sales ($m)|
|Rimegepant||Biohaven Pharmaceutical Holding||54||261||484|
|*Preventive treatment. Source: EvaluatePharma|