The U.S. FDA (Food and Drug Administration) seemed self-confident to permit brexanolone, which is a postpartum depression (PPD) drug. This drug is developed by Sage Therapeutics. There are currently no FDA-accepted drugs to particularly take care of PPD. The PPD is an extreme version of the self-styled “baby blues” several women have after childbirth.
Some side effects led the FDA to advise a monitoring time period after women get the injection and recommended in contrast to the home use of a drug. According to the FDA, during the trial, 6 of the 140 women exposed to brexanolone felt sedation, at least one losing consciousness linking to the drug and another experiencing from sleep apnea. But the small sampling of women, who encountered those side effects, did not compare with the destructive shocks of postpartum depression on mothers, their families, and children. PPD is typically deal with antidepressants, which can take almost 4 to 6 Weeks to knock down. According to the Mayo Clinic, that is a schedule that does not treat PPD patients well, considering the extreme environment of PPD it can make new mothers feeling restless, hopeless, or even suicidal.
Recently, FDA was also in news for giving approval to pegfilgrastim biosimilar. The FDA has given an approval to pegfilgrastim-cbqv for patients with cancer who are receiving myelosuppressive chemotherapy, as per Coherus BioSciences who is the maker of an agent. The biosimilar also established approval by the EC (European Commission). Denny Lanfear—Chairman, CEO, and President of Coherus BioSciences—stated that the company is excited for receiving FDA approval for Udencya. He further added that the list cost of Neulasta has nearly increased three times since approval in 2002 and now has a $4 Billion annual cost burden in the U.S. Coherus BioSciences believes that a healthy competition is needed in managing burdensome price elevation and Udencya will play a chief role in cutting that spend when launched.