Following an almost yearlong wait, FDA approves Axsome's rapid-acting depression drug
After a nearly 365-day delay, Axsome Therapeutics has secured its first drug approval with an FDA green light for Auvelity as a treatment for adults with major depressive disorder.
The biotech is keeping shy on the pricing for now and, on an investor call, CEO Herriot Tabuteau attributed the FDA’s yearlong delay mainly to the Covid-19 pandemic. The rapid-acting NMDA receptor antagonist is not a scheduled drug under the DEA, the CEO confirmed on the call.
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