FDA OKs BioMarin's cerliponase alfa for type of Batten disease; shares ahead 1%

|About: BioMarin Pharmaceutica... (BMRN)|By:, SA News Editor

The FDA approves BioMarin Pharmaceutical's (BMRN +1.5%) Brineura (cerliponase alfa) for the treatment of symptomatic pediatric patients with a form of Batten disease called late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) also known as tripeptidyl peptidase-1 deficiency.

Batten disease is a relatively rare inherited disorder that occurs in 2 - 4/100K live births in the U.S. in which the body's cells lose their ability to dispose of wastes.

The company's marketing application in Europe should be approved in June.

Previously: BioMarin delivers long-term efficacy data to FDA showing prolonged treatment effect in children with Batten disease treated with cerliponase alfa; PDUFA date extended to April 27, 2017 (Sept. 7, 2016)