Posted by Michael Wonder on 15 Mar 2021
PharmaEssentia provides U.S. regulatory update on ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
14 March 2021 - PharmaEssentia Corporation today announced that the U.S. FDA has issued a complete response letter for the company’s biologics license application for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera.
The rationale for the complete response letter was COVID-related travel restrictions, which delayed a required pre-approval inspection of the company’s manufacturing facility in Taiwan.
The FDA also indicated a need for additional data about the administration format with the product.
