Allergan scores year-end FDA nod for CGRP migraine med Ubrelvy, plans early 2020 launch

FDA Building 2
Amgen scored approval for CGRP migraine med Ubrelvy. (FDA)

The CGRP migraine prevention field already has three meds from Amgen, Eli Lilly and Teva vying for market share, and now Allergan has scored the first approval for an oral CGRP to treat migraines as they happen.

Allergan’s Ubrelvy, formerly known as ubrogepant, passed FDA gatekeepers Monday, becoming the first oral CGRP drug for the acute treatment of migraines. The med is expected to face 2020 competition from Biohaven’s rimegepant. Allergan plans to launch in the first quarter next year.

In clinical trials, the drug provided fast pain relief for a majority of patients compared with placebo. It also helped with other symptoms such as nausea as well as light and sound sensitivity. It’s a “much-welcomed development for me and for many who care for patients,” King's College professor and neurologist Peter Goadsby, M.D., said in a statement

Watch the Free Webinar

Chemistry Through Biology: Translating Molecular Biology Technologies into Practical Processes for API Production

Learn about the key advances and critical hurdles in transforming emerging molecular biology technologies into practical applications with commercially viable processes.

EvaluatePharma analysts have predicted the drug will generate $302 million by 2024.  

RELATED: Can Biohaven challenge the Allergan/AbbVie goliath in migraine? CEO Coric thinks so 

The migraine field has seen a surge of activity with three CGRP approvals last year and their corresponding launches. Amgen shot out to a lead with its market-first Aimovig, but Eli Lilly has been gaining steam lately with Emgality. 

Lilly then scored FDA approval for Emgality to treat cluster headaches, plus another FDA nod for new migraine treatment Reyvow. The company expects to launch Reyvow in early 2020 after DEA scheduling. 

Meanwhile, Allergan is set to combine with AbbVie next year under a merger the companies inked in June. 

Suggested Articles

Pfizer and Merck KGaA’s Bavencio is heading toward a piece of the crowded bladder cancer market that it can call its own.

IDEA Pharma ranks AstraZeneca at the top of the pharma invention scale, and Roche became king in the land of innovation.

Will Pfizer's Braftovi-Erbitux combo in BRAF-mutated colon cancer be the standard of care? Adding Mektovi may be the real opportunity, some predict.