MS drugs from Biogen Idec, Genzyme get recommendations from European panel

A panel that advises European regulators has issued a positive opinion on a multiple sclerosis drug candidate from Biogen Idec Inc.

A Weston company known for such MS drugs as Avonex and Tysabri, Biogen Idec said in a Friday press release that it has received a positive opinion on its MS drug candidate Tecfidera from the Committee for Medicinal Products for Human Use, or CHMP. The CHMP is recommending that European Union regulators grant market authorization for Tecfidera as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis.

A decision on Tecfidera by the US Food and Drug Administration is expected shortly.


“We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy,’’ Biogen Idec chief executive George A. Scangos said in a statement.

Earlier this week, Biogen Idec announced that the US Patent Office had granted it broad protection for Tecfidera.

Avonex is typically injected once a week. Tysabi is generally taken by infusion once a month. And Tecfidera is envisioned as a capsule that patients would take twice a day.

Meanwhile, Genzyme, now a Cambridge-based unit of French drug maker Sanofi SA, also said that the CHMP has issued a positive opinion regarding the approval of Aubagio, its MS drug candidate for adults with relapsing-remitting MS.

Aubagio, which is taken orally, has already been approved to treat relapsing MS in the United States and Australia, Genzyme said in its press release.

In a statement, Genzyme CEO and president David Meeker expressed disappointment that the CHMP did not recommend that Aubagio receive a new active substance (NAS) designation.

“We are very disappointed about the CHMP opinion regarding new active substance designation,’’ Meeker said. “We believe based on the product’s characteristics and current data that Aubagio is a new active substance. Aubagio has been studied over 10 years in one of the largest and broadest clinical development programs of any MS therapy. This decision could have a detrimental impact on future scientific innovation in MS and other diseases. We are considering all options and planning to request a re-examination of the new active substance designation.’’

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