The U.S. Food and Drug Administration accepted for review Impel NeuroPharma’s 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.
BioSpace reviewed the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.
Axsome Therapeutics reported positive data from the long-term, open-label Phase III MOVEMENT trial of AXS-07 for the treatment of acute migraine.
Eli Lilly and Company announced positive results from CENTURION, the company’s Phase III study looking into Reyvow (lasmiditan) for migraine attacks.
Dr. Reddy’s Laboratories Ltd. received approval for Elyxyb (celecoxib oral solution 25 mg/mL) from the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Eli Lilly priced the company’s acute migraine treatment Reyvow at $640 for a pack of eight pills.
Biohaven Pharmaceutical Holding Company Ltd. said two doses of an experimental treatment for acute migraine were effective in reducing headaches in a large study, sending the company’s shares up 8 percent.
The U.S. Food and Drug Administration approved Eli Lilly and Co.’s Reyvow, representing the first new class of acute migraine treatment approved by the regulatory agency in more than two decades.
Biohaven Pharmaceutical Holding said the company’s treatment for acute migraine cleared two late-stage studies, but investors worried about its commercial viability as the efficacy data failed to distinguish from Allergan’s rival treatment.