Biogen Idec Gets FDA Approval To Market Injectable MS Treatment In U.S.

The U.S. FDA has given Biogen Idec the go ahead to market Plegridy, its new injectable drug to treat adults with the chronic autoimmune disease Multiple Sclerosis (MS).

This new drug was approved as a “longer lasting” treatment for relapsing-remitting MS, just a month after the EU approved the company to sell the medicine in 28 countries, according to the Boston Globe.

Plegridy contains the same API, interferon beta, as Biogen’s other MS drug, Avonex. However, Plegridy features an attached polymer called polyethylene glycol (PEG) that increases the exposure of the drug so patients don’t have to take it as often. For example, while Avonex has to be injected once a week, Plegridy only needs to be administered by injection every two weeks, via a prefilled auto-injector.

MS affects the central nervous system of at least 400 thousand people in the U.S. and more than 2.3 million globally, disrupting communication between the brain and other body parts. Gradually the disease causes muscle weakness, loss of balance, and a progressive decline in physical functions. With this sort of impact, Gilmore O’Neill, VP of MS R&D at Biogen believes Plegridy is an attractive choice for those suffering with the disease. “It gives patients another choice,” he said.

“Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” Biogen CEO George A. Scangos, Ph.D. added. 

Biogen is not yet sure of the market size for Plegridy nor has it disclosed the pricing. But the company does expect the price to be similar to Avonex, which costs just over $59,000 per patient annually.

Interferon vs. Oral MS Treatments

Thus far, oral treatments for MS have been the fastest growing segment in the market.  In fact, Biogen is the largest seller of MS medicines overall, boasting Tysabri in its portfolio for people with more severe forms of the disease, as well as best-selling MS pill Tecfidera.

However, interferon drugs continue to expand, and are now prescribed to treat about 50 percent of people with MS.

“Interferons have an important place,” O’Neill said. “When patients find a mechanism of action that works for them, they want to stick to it.”

Although Biogen does not plan to discontinue sales of Avonex, it is looking to gradually transition many patients from Avonex and other first-generation interferons to the longer-lasting Plegridy.