BioMarin says FDA extends Kuvan market exclusivity by six months

BioMarin Pharmaceutical announced that the FDA granted KUVAN Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension. The FDA action extends KUVAN's market exclusivity to June 2015 and is based on studies submitted in response to a written request by the FDA to investigate the use of KUVAN in pediatric patients from birth to age 6. KUVAN formulated as Tablets and Powder for Oral Solution, is the first and only FDA-approved medication for PKU to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.