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.
Drugmaker Eli Lilly and Co. said its acute migraine drug lasmiditan succeeded in a key late-stage study, setting the stage for U.S. regulatory approval.