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BioMarin Withdraws EMA Application for DMD Candidate, Halts Work

June 7, 2016

BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate.

The company’s decision to withdraw its EU application for Kyndrisa and halt work on the candidate comes four months after the FDA rejected an application for the drug, asking in a complete response letter for more proof of the candidate’s benefits.

According to the company, it decided to pull the marketing application for the EU after a CHMP hearing in May “clearly indicated” that CHMP would issue a negative opinion.

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