« PharmaEssentia Corporation a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer. »
PharmaEssentia Provides U.S. Regulatory Update o... - MPN Voice
PharmaEssentia Provides U.S. Regulatory Update on Ropeginterferon alfa-2b-njft for the Treatment of Polycythemia Vera (PV)
![Manouche profile image](https://images.hu-production.be/avatars/a3b96d3f503b47bbbcb94ae844837ba1_small@2x_100x100.jpg)
Written by
![Manouche profile image](https://images.hu-production.be/avatars/a3b96d3f503b47bbbcb94ae844837ba1_small@2x_100x100.jpg)
Manouche
To view profiles and participate in discussions please or .
2 Replies
•
« 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. »
Hopefully the FDA will be able to complete the process ASAP. It is unfortunate that the COVD travel restrictions are slowing things down, but not a big surprise. '
Hope we all get good news soon.
Not what you're looking for?
You may also like...
FDA Issues Complete Response Letter for Ropeginterferon Alfa-2b for Polycythemia Vera
com/view/fda-issues-complete-response-letter-for-ropeginterferon-alfa-2b-for-polycythemia-vera
Ropeginterferon Alfa-2b listed as Preferred Treatment in Polycythemia Vera
Guidelines in Oncology have been revised to include ropeginterferon alfa-2b-njft as a preferred...
Cost–effectiveness of ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
results suggest the benefits of treatment with ropeginterferon alfa-2b-njft outweigh the costs for a
FDA Rejects Ropeginterferon alfa-2b for Polycythemia Vera
https://patientworthy.com/2021/03/22/fda-rejects-ropeginterferon-alfa-2b-polycythemia-vera/
Effective Management of Polycythemia Vera With Ropeginterferon Alfa-2b Treatment
new dosing regimen of 250-350-500 µg of ropeginterferon alfa-2b is well-tolerated and highly...