Singulair gets MedWatch alert for suicide risk
FDA will likely need nine months to review data potentially linking Merck's asthma treatment Singulair (motelukast) to behavior/mood changes, suicidality and suicide, the agency says in a March 27 MedWatch alert. FDA attributes the lengthy evaluation time to the complexity of the analyses. Merck updated its label four times in the past year to add post-marketing adverse events including tremor, depression, suicidality and, most recently, anxiousness
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.