BioMarin Pharmaceutical (BMRN) shares are higher after the company said Monday that the U.S. Food and Drug Administration (FDA) granted KUVAN powder a six-month pediatric exclusivity extension.
Shares are up 1.26% at $57.97, with a 52-week range of $53.53 – $84.25.
The company, which develops and commercializes therapies for rare genetic diseases, said 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 only FDA-approved medication for phenylketonuria (PKU) to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet.
PKU or PAH deficiency is a rare genetic condition in which the body cannot process Phe, an amino acid found in many foods.