On November 2, two FDA advisory committees voted in favor of Zulresso (brexanolone, Sage Therapeutics, Cambridge, Massachusetts), a rapid-acting agent for the treatment of post-partum depression (PPD) in women.
If brexanolone is approved, it will have a profound effect on the lives of the almost 400,000 women in the U.S. who are diagnosed annually with the illness. During clinical trials, within two-and-a-half days of taking the medication, women showed a remarkable and fast improvement in their depression scores. The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 17 to 1 in favor of brexanolone’s benefit–risk profile.
Close to one in nine women in the U.S. suffer from symptoms of PPD after giving birth. These symptoms can include sadness, anxiety, irritability, social withdrawal, trouble bonding with the baby, and thoughts about self-harm or causing harm to the baby.
In 2017, the FDA granted brexanolone breakthrough therapy designation for severe and moderate PPD, and the drug received a similar status from the European Medicines Agency (EMA). Currently, brexanolone is in phase 3 for PPD and is being reviewed by the FDA under priority review status. Although not bound by advisory committee recommendations, the agency usually follows their suggestions, and Zulresso has a target Prescription Drug User Fee Act (PDUFA) date of December 19, 2018.
Source: BioSpace.com, November 6, 2018