Biogen Idec submits FDA application for promising MS drug

By Chris Reidy, Globe Staff

Biogen Idec Inc., a Weston-based biotechnology company known for its multiple sclerosis drugs, said it has submitted a New Drug Application to federal regulators to get approval to market a potential new MS treatment known as BG-12.

In December, Biogen Idec shares hit their high for 2011 after the company released promising results from a clinical trial of BG-12.

BG-12, the company’s designation for dimethyl fumarate, would be taken twice a day in pill form, and it is designed to treat of relapsing-remitting multiple sclerosis, sometimes called RRMS, the most common form of MS, Biogen Idec said in a press release.

Two other Biogen Idec MS drugs are delivered differently. Tysabri is administered in a once-a-month infusion, and Avonex is injected once a week, the company said.

Biogen Idec, which said today that it had submitted a New Drug Application to the US Food and Drug Administration, added that it plans to submit a similar request to European regulators within the next few days.

Biogen Idec said it anticipates hearing from regulatory authorities regarding the status and acceptance of its BG-12 submissions “within the next couple of months.”

In a separate press release this morning, the company said the FDA has approved two separate dosing innovations designed to improve the treatment experience for patients receiving Avonex. Currently, Avonex is delivered by syringe. What the FDA has approved is an “auto-injector” device for delivering a dose of Avonex. Because the auto-injector’s needle is thinner and shorter than that of a syringe, the hope is that the auto-injector will make things easier for patients.

Chris Reidy can be reached at reidy@globe.com.

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Biogen Idec submits FDA application for promising MS drug