Top Neurologists Concerned About FDA Decision to Approve MS Drug

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Top Neurologists Concerned About FDA Decision to Approve MS Drug

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March 2002 (Newstream) --

SUGGESTED ANCHOR LEAD: The FDA has approved the multiple sclerosis drug Rebif,

overturning the Orphan Drug

marketing exclusivity for the leading MS therapy, Avonex. There has been a great

deal of debate in the medical

community leading up to this ruling, with top neurologists critical of the data

that lead to the drug's approval. a

Facinelli has the story. (1:08)

SCRIPT: Leading neurologists are concerned about the FDA's decision to allow the

multiple sclerosis drug Rebif on the

market. Rebif is the same molecule as Avonex, currently the most prescribed MS

drug in the U.S. Avonex had FDA-

granted marketing exclusivity under the Orphan Drug Act until mid-2003, but this

decision overturns that. Some doctors

question the scientific rigor behind the study, called the EVIDENCE trial, that

lead to this decision. Dr. Stuart is the

medical director of the MS Center of Atlanta.

CUT: (DR. STUART) " I think that the entire issue of trying to get approval

through the Orphan Drug Act by Rebif, and the

creation of the EVIDENCE trial, was somewhat disingenuous, and was based on

marketing issues rather than science

issues. "

SCRIPT: Under FDA regulations, a product must prove " clinical superiority " to

overturn another product's orphan drug

marketing exclusivity.

CUT: (DR. STUART) " I don't think that Rebif is clinically superior to Avonex.

You have to factor into any drug that you

use over ten years the concepts of side effect, of compliance, neutralizing

antibodies, how the drug is taken. "

SCRIPT: I'm a Facinelli.

SUGGESTED ANCHOR TAG: The Orphan Drug Act was designed to provide incentives for

companies to invest

resources to develop treatments for diseases that afflict a relatively small

number of people. For complete prescribing

information, visit www.Avonex.com.

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Produced for Biogen

Contact:

Larry Gamache/ Langfelder

202-628-3800