Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera, a rare blood cancer.
The resubmission follows receipt of a complete response letter in March, in which the FDA sought additional information about the administration format with the product. Importantly, no concerns were raised about the clinical profile of the product.
Also noted were COVID-related restrictions that delayed the required pre-approval inspection of the company’s manufacturing facility in Taiwan.
