Roche’s BLA for the first therapy for patients with primary progressive multiple sclerosis has been delayed by the US FDA due to manufacturing issues, the company announced Dec. 20. The PDUFA date for Ocrevus (ocrelizumab) has been extended by three months until March 28, so that the agency can review additional data submitted by Roche’s Genentech unit related to the commercial manufacturing process for the drug.
“The extension is not related to the efficacy or safety of Ocrevus,” Roche said in a statement. A failure to demonstrate manufacturing readiness has been one of the more common reasons for complete response letters (CRLs). Manufacturing issues accounted for one of every five CRLs in which the reason was disclosed, according to the Pink Sheet’s FDA Performance Tracker