2 days ago
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
June 13 (Reuters) - The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' (KALV.O), opens new tab drug for a type of hereditary swelling disorder due to heavy workload and limited resources, the company said on Friday.
The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said.
The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator.
The extension is the latest instance of the FDA missing a deadline following mass layoffs under a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.
The regulator also missed the target date for GSK's Nucala to treat smoker's lung.
KalVista said the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat.
The company also said it has addressed all prior information requests in a timely manner and believes the only remaining item under FDA review is the finalization of the packaging insert.
