In early March the U.S. Food and Drug Administration (FDA) approved Serono’s Rebif® (interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS), thereby breaking the orphan status of Biogen’s Avonex®‚ (interferon beta-1a). The two drugs are similar.

The approval of Rebif® was based upon data from the PRISMS study and the head-to-head EVIDENCE study, which showed that Rebif® is clinically superior to Avonex® at 24 weeks, within the terms of the Orphan Drug Act (ODA). Rebif® is approved in over 70 countries, but until now, Rebif® could not be marketed in the US due to the orphan drug protection of Avonex®, whose exclusivity under the ODA was granted in 1996 and was not due to expire until May 2003. Avonex® now remains an orphan drug in name only.

Drugs that treat a disease that affects fewer than 200,000 people in the US can be designated as “orphan drugs.” Companies developing such drugs receive tax credits, protocol assistance, research grants, and as much as a 7-year monopoly on drug sales. The 7-year exclusivity can be overturned if a new drug yields either better treatment results or an improved safety profile. This is the first time, since the implementation of the U.S. ODA 19 years ago, that a product’s orphan exclusivity has been overturned based on efficacy. ( www.pjbpubs.com and www.biospace.com/news)

This entry was posted on Tuesday, July 9th, 2002 at 3:55 pm and is filed under All Articles, Medications, Multiple Sclerosis News. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.