PharmaEssentia receives CRL for Biologics License Application from FDA
Category: #health  By Pankaj Singh  Date: 2021-03-15
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PharmaEssentia receives CRL for Biologics License Application from FDA

PharmaEssentia Corporation, a biopharmaceutical innovator, has recently received a CRL (complete response letter) from the U.S. FDA for its BLA (Biologics License Application) regarding ropeginterferon alfa-2b-njft, a medication for use in the treatment of PV (polycythemia vera), which is a rare blood cancer.

Founded in 2003 by a group of Taiwanese-American executives & aspiring scientists from the biotechnology and pharmaceutical companies in the U.S., PharmaEssentia Corporation has been leveraging its proven scientific principles and deep industry expertise to consistently offer new biologics in oncology and hematology. For the record, one of its products has been approved for use in Europe. Presently, it has a global presence across Japan, the U.S., China, and Korea. Additionally, it has also been operating a leading biologics production plant in Taichung.

Ropeginterferon alfa-2b-njft is a medication that has received the Orphan Drug designation to treat, prevent, or diagnose patients suffering from PV in the United States. Sold under the brand name Besremi® in Europe, the product also gained the EMA (European Medicines Agency)’s approval for medical use in 2019. The molecule was launched and is manufactured by PharmaEssentia Corporation.

The rationale for the recent complete response letter was COVID-19-related travel restrictions that have delayed a required pre-approval inspection of its manufacturing plant in Taiwan. Reportedly, the U.S. FDA has required the company to provide additional data on the administration format of ropeginterferon alfa-2b-njft. No concerns have been raised so far about the product’s clinical profile.

According to the U.S. General Manager, Meredith Manning, PharmaEssentia Corporation is planning to extensively collaborate with the federal agency to address the requests included in the response letter, as well as quickly resubmit it. The company is committed to launching the approved ropeginterferon alfa-2b-njft to the community suffering from polycythemia vera in the United States.

Source credit:

https://www.businesswire.com/news/home/20210314005021/en/PharmaEssentia-Provides-U.S.-Regulatory-Update-on-Ropeginterferon-alfa-2b-njft-for-the-Treatment-of-Polycythemia-Vera-PV



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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