Biogen Idec seeks OK from the FDA for the next Oral MS Medication

The company asked the FDA to grant priority review for the pill, which would result in a decision in six months rather than the standard 10. In either case, Biogen Idec would probably be able to start marketing it by the end of the year. Later this week, the company is also planning to apply for approval from European regulators to sell the pill, a process that could take a year.

Biogen Idec also disclosed yesterday that the FDA approved two dosing innovations for patients taking Avonex, an MS treatment that has been on the market for 15 years. One is an intramuscular autoinjector using a smaller needle that is easier for patients to tolerate. The other is a dosing regimen that reduces the incidence and severity of flu-like symptoms that the treatment can sometimes cause.

In the case of both Avonex and BG-12, “we’re trying to improve the patient experience,’’ Williams said. “It’s clearly a theme that we’re trying to put in place.’’ Biogen Idec also sells Tysabri, a multiple sclerosis drug for patients with advanced forms of the disease.

Dr. Daniel Kantor, president of the Florida Society of Neurology, said one of his first reactions to BG-12 was “wow!’’ Kantor called the pill a potential “blockbuster in the MS market.’’

“BG-12 is going to fundamentally change how I approach [treating] multiple sclerosis,’’ he said.