FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

NICE Recommends MS Drug Tecfidera

Sept. 5, 2014

Biogen Idec said it will launch its multiple sclerosis drug Tecfidera within three months in England and Wales following a final coverage recommendation from the UK healthcare pricing watchdog.

The National Institute for Health and Care Excellence recommended Tecfidera (dimethyl fumarate) for patients whose relapsing-remitting MS is not highly active or rapidly evolving, NICE spokeswoman Elizabeth Adelanwa said. The drug’s European marketing authorization covers all adults with relapsing-remitting multiple sclerosis.

The NICE guidance is good news for people in England and Wales who are starting treatment for RRMS, said Biogen spokeswoman Shannon Altimari. “This is important as approximately 100,000 people in the UK have MS,” she said.

The final clearance Wednesday follows NICE’s positive recommendation of the drug in July, a decision that reversed its earlier negative recommendation. Tecfidera won FDA and EMA approval in March. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.