=Amgen (AMGN): FDA has accepted for review the BLA for Aimovig

Amgen announces that the FDA has accepted for review the BLA for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month :

The BLA for Aimovig includes data from pivotal studies of more than 2,600 patients experiencing four or more days of migraine per month.

• Phase 2 and Phase 3 clinical studies of Aimovig versus placebo have demonstrated a reduction in the number of migraine-affected days, disability and acute medication use for patients with episodic and chronic migraine.
• The safety profile of Aimovig was similar to placebo across all treatment arms in the Phase 2 and Phase 3 studies for up to six months.
• The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.

The FDA has set a Prescription Drug User Fee Act (:PDUFA) target action date of May 17, 2018.