Alder BioPharmaceuticals files for FDA approval of CGRP inhibitor eptinezumab to prevent migraines

Alder BioPharmaceuticals on Friday announced that it has submitted the investigational CGRP inhibitor eptinezumab for FDA approval for the prevention of migraine. The drugmaker indicated that if cleared, eptinezumab could potentially be launched in the first quarter of next year, with CEO Bob Azelby noting it would "be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective and sustained suppression of migraine."

Alder's submission includes data from the Phase III PROMISE 1 and PROMISE 2 studies. In PROMISE 1, eptinezumab significantly reduced the number of monthly migraine days versus placebo after 12 weeks in patients suffering from frequent episodic migraine, with later results showing further reductions in migraine following the third and fourth quarterly infusions.

Meanwhile, six-month data from PROMISE 2 demonstrated that 43 percent of chronic migraine patients receiving eptinezumab achieved a reduction of monthly migraine days of at least 75 percent, while one in five patients in the trial were migraine free on average per month following the second infusion.

An analyst suggested last month that eptinezumab could eventually capture 15 percent to 20 percent of the migraine market, with Biogen potentially targeting Alder in a takeover.

Amgen and Novartis' Aimovig (erenumab-aooe) became the first CGRP inhibitor to gain US approval following its clearance last year for migraine prevention. The FDA has since approved two other anti-CGRP therapies to prevent migraines, Teva's Ajovy (fremanezumab-vfrm) and Eli Lilly's Emgality (galcanezumab-gnlm).

Allergan is expected to submit its oral CGRP receptor antagonist ubrogepant for FDA approval for the acute treatment of migraine by the first quarter, while Eli Lilly has already applied to have its selective serotonin 5-HT1F agonist lasmiditan cleared in the US for the acute treatment of migraine, with or without aura.

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