Kate Dawson, VP of Medical
       Affairs at Biogen
Biogen presented follow-up data from the second year of patients taking Plegridy, a once-a-month or once-every-other-week injected drug awaiting an approval decision in the U.S. as well as Europe. In the study, Plegridy was shown to continue helping patients manage relapses versus a placebo.

U.S. regulators accepted Biogen’s application for approval of Plegridy last July, and recently extended its deadline to approve the drug by three months. A decision is expected in coming months.

Plegridy represented a return to interferon-based drugs for Biogen, whose last two approved drugs for MS have not relied on interferons due to the fact that they cause flu-like symptoms in many patients. Dawson said that “there are still a lot of patients that are getting benefits from interferons” despite the side effects, which are often mild. There have been no new interferon-based drugs approved for MS in more than a decade.

While Biogen’s first MS drug, Avonex, which was approved in 1996, also includes interferons, Plegridy would require less frequent dosing and is administered using a smaller needle, Dawson said.

Labels: Biogen, Plegridy