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BioMarin Pharma: EMA Adopts Positive Opinion On MAA For Palynziq Injection

BioMarin Pharmaceutical Inc. (BMRN) announced the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion for the company's Marketing Authorization Application for Palynziq (pegvaliase) Injection to reduce blood phenylalanine (Phe) concentrations in patients with phenylketonuria aged 16 and older, who have inadequate blood Phe control despite prior management with available treatment options. The European Commission is expected to make its final decision on Palynziq in second quarter, 2019, the company said.

In May 2018, Palynziq, a PEGylated recombinant phenylalanine ammonia lyase enzyme, received regulatory approval from the U.S. Food and Drug Administration, making it the first approved enzyme substitution therapy to target the underlying cause of phenylketonuria by helping the body break down blood phenylalanine, or Phe.

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