WASHINGTON (dpa-AFX) - BioMarin Pharmaceutical Inc. (BMRN) announced the FDA has accepted for Priority Review the company's PALYNZIQ supplemental Biologics License Application to expand treatment to include adolescents aged 12-17 with phenylketonuria. The FDA has set a PDUFA target action date of Feb. 28, 2026. The sBLA is based on data from PEGASUS, a Phase 3 multi-center open-label randomized controlled study.
The company said it is also working to share the data with the European Medicines Agency with the goal of expanding treatment with PALYNZIQ to include adolescents as young as age 12 in the European Union.
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