U.S. FDA Approves Pharma Essentia’s BLA Resubmission

FDA, U.S., has accepted PharmaEssentia’s BLA request for peginterferon alfa-2b-njft targeting Polycythemia Vera (P.V.) treatment. PharmaEssentia Corp. is based in Taiwan and has its subsidiary PharmaEssentia USA Corporation, Burlington, Massachusetts.

It is a global biopharmaceutical innovator invested in developing therapeutic solutions for patients suffering from myeloproliferative neoplasms (MPNs), and other hematology-associated diseases. PharmaEssentia has leveraged its greater expertise in the field and proven scientific concepts to deliver novel biologics in oncology and hematology.

They announced on June 03, 2021; the United States FDA has accepted the company’s resubmission of the Biologics License Application (BLA) requesting approval for utilization of peginterferon alfa-2b-njft for P.V. treatment.Polycythemia Vera (P.V.) belongs to the blood cancer family with extremely rare characteristics with unmet medical attention. FDA has allocated a time span of six months for reviewing the resubmitted application. FDA has set November 13, 2021, as the establishment day for Target Prescription Drug User Fee Act (PDUFA). Currently, peginterferon alfa-2b-njft comes under the class of Orphan Drug for the treatment of P.V. and is not manufactured on a commercial scale in the United States.

Meredith Manning, U.S. General Manager addressed the FDA acceptance of the company’s resubmitted application to be positive, and an influential step, escalating the scope for peginterferon alfa-2b-njft in Polycythemia Vera treatment working alongside the agency.The drug has been marketed in Europe as Besremi ® approved by the European Medicines Agency (EMA) back in 2019. PharmaEssentia was established in 2003 by a group of Taiwanese-American executives and eminent scientists from U.S. biotechnology and pharmaceutical companies.