BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) recently declared that the United States. The Food and Drug Administration (FDA) will need additional time to complete its evaluation of the Biological Licensing Application (BLA) for its pegvaliase test therapy,
A Phenylalanine ammonia lyase enzyme produced by recombinant phenylalanine, to decrease phenylalanine levels (Phe) in adults with phenylketonuria (PKU) who have uncontrolled levels of Phe in blood in the administration obtainable.
Due to the Fall Day weekend, the date of the act date will be May 25 of next year.
In a notice received from the FDA, the Reference Date of the Fee for Prescription Drug Users Act (PDUFA) for pegvaliase has been extended for three months until May 28, 2k18.
On August 29, 2k17, when the standard of the FDA BioMarin’s BLA and granted the status of review of the main concern, the organization stated that the FDA had requested additional information on Chemistry,
Manufacturing and Controls (CMC), which probably it was confidential as a major alteration of the BLA and as a result an addition of 3 months from the date of the PDUFA.
Predictably, the FDA designated the receipt of this additional information as an important adjustment to the application, thus extending the date of the PDUFA action for three months.
Said Hank Fuchs, M.D., President of Global Research and Development at BioMarin:
We are very happy with our ongoing connections with the FDA in the BLA pegvaliase.
We continue to work intensively with the FDA and look forward to the opportunity to bring this meaningful treatment to patients.
We are grateful for the ability of the FDA to expedite the review through the designation of the main concern, primarily for this complex disease and treatment, said Hank Fuchs, M.D., President of BioMarin’s Global Research and Development.
The FDA decided:
The FDA has determined the priority review term for penalization, which is agreed with drugs that treat a serious condition and,
if they are standard, would provide a remarkable development in the safety or efficiency of the treatment, prevention or diagnosis of a disease. serious.