FDA says no adcomm planned for Biogen, Sage's depression drug
The FDA will not require Biogen and Sage Therapeutics’ new depression drug to go before an advisory committee, the companies said Wednesday morning.
The drug, known as zuranolone, is designed to be a rapid-acting treatment for severe depressive episodes in patients with major depressive disorder and postpartum depression. Patients take the oral drug once per day for two weeks.
Sage’s chief development officer Jim Doherty told Endpoints News that before this morning, the company had not heard from the agency whether an adcomm was going to be required.
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