With a full slate of injectable CGRP migraine drugs positioning themselves at the finish line for FDA approvals for chronic cases, Allergan $AGN today took another big step forward with its pill for acute cases. The company hailed a Phase III win for its first late-stage test of ubrogepant, one of the migraine drugs it acquired from Merck a little more than two years ago.
Researchers say the drug hit both of the co-primary endpoints for acute migraine, with a statistically significant beat for a placebo arm in being pain free and free of most symptoms of migraine two hours after initial treatment.
Allergan plans to publish more of the data later in the year, with the second Phase III readout coming in the first half of 2018. Allergan execs in turn expect that will set up an NDA for next year.
Meanwhile, Amgen and Novartis are in the lead on the injectable side of the CGRP race, with the FDA reviewing their drug, Aimovig. The drug will likely be challenged by a group of competitors ranging from Eli Lilly $LLY to Teva $TEVA and Alder $ALDR that have all demonstrated broadly significant data in cutting the number of migraine days experienced by a chronic sufferer.
Committed to innovation in #migraine treatments. @Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant – an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine https://t.co/ytP2W1CpW5
— Brent Saunders (@brentlsaunders) February 6, 2018
“We are pleased with the favorable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant. We are confident that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist will be an option for the treatment of migraines in adults,” said David Nicholson, Allergan’s head of R&D. “Allergan remains committed to identifying, developing and bringing to market therapies that address unmet need for patients suffering from this debilitating disease.”
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