More MS news articles for Mar 2002

FDA Approves Rebif® For Relapsing Forms Of MS

http://www.nationalmssociety.org/Research2002-Mar8.asp

March 8, 2002

Summary:

The U.S. Food and Drug Administration (FDA) has approved for marketing Rebif® (Serono Inc., Geneva, Switzerland), a form of interferon beta-1a, for treatment of relapsing forms of MS.

The FDA approval was based on results from the PRISMS study, an international, multicenter clinical trial which tested two doses of Rebif or placebo, and a direct “head-to-head” comparison study of Rebif and Avonex in the EVIDENCE trial. Rebif was prevented from being on the market in the U.S, until 2003, unless “clinical superiority” of Rebif over Avonex could be demonstrated.
It is expected that Rebif will be available immediately in the US. Pricing information has not yet been announced.

There are now five drugs – Avonex, Betaseron, Copaxone, Novantrone and Rebif – approved in the U.S. for treating the major forms of MS. The decision of which therapy is best for any individual should be determined in consultation with his or her personal physician.

Details:

The U.S. Food and Drug Administration (FDA) has approved for marketing Rebif® (Serono Inc., Geneva, Switzerland), a form of interferon beta-1a, for treatment of relapsing forms of MS. (Relapsing forms of MS involve clearly defined disease relapses with full recovery or with residual deficit upon recovery.)  It is expected that Rebif will be available immediately in the U.S. Pricing information has not yet been announced.

The FDA approval was based on results from two clinical trials. One, the PRISMS study (Prevention of Relapses and Disability by Interferon beta-1a, Rebif, Subcutaneously in MS), was an international, multicenter clinical trial conducted at 22 centers in Europe, Canada and Australia which tested two doses of Rebif or placebo, self-administered three times a week for two years. This study showed that Rebif caused a statistically significant reduction in relapse number and frequency, slowed progression of disability and reduced lesion activity in the brain, determined by MRI.

Results from the PRISMS trial were first announced in 1997, and based on those results, Rebif is available for use in MS in over 60 countries worldwide. An application for marketing approval in the United States was not approved then by the FDA because of provisions of the Orphan Drug Act that provide incentives for pharmaceutical companies to develop medications for relatively rare disorders. One provision, a market exclusivity for a first new drug for a condition for seven years, was in place for Avonex (Biogen Inc.), the interferon beta-1a product available for relapsing-remitting MS that was approved by the FDA in 1996. Because of this provision, Rebif was prevented from being on the market in the U.S, until 2003, unless “clinical superiority” of Rebif over Avonex could be demonstrated.

With this in mind, Serono Inc. undertook a direct “head-to-head” comparison study of Rebif and Avonex in the EVIDENCE trial (Evidence for Interferon Dose Effect: European-North American Comparative Efficacy). The trial was designed based on Serono’s belief that Rebif, delivered at 44 mcg three times a week, injected subcutaneously, would perform better than Avonex, delivered at its standard dose (30 mcg once a week, injected intramuscularly). The EVIDENCE study was a short-term, six-month trial involving 677 individuals with relapsing-remitting MS, half receiving Rebif and half receiving Avonex. The six-month treatment results were in favor of Rebif on all primary and secondary outcomes of the trial, including fewer relapses and reduced accumulation of lesions in the brain detected by MRI in those treated with Rebif compared to those treated with Avonex. Both agents were found to be tolerable, although Rebif caused increased side effects (injection-site reactions, liver function disorders and reduced white blood cell counts) compared to Avonex.

Conclusions:

In approving marketing of Rebif for relapsing forms of MS prior to mid-2003, the FDA signaled its view that this form and dose of interferon beta-1a provided benefit for individuals with relapsing forms of  MS (from the original PRISMS study) and that, at least within the confines of the EVIDENCE study, Rebif showed superiority over Avonex. How these drugs compare in terms of effectiveness and tolerability in longer-term, regular use remains to be seen.

With the addition of Rebif, there are now five drugs – Avonex, Betaseron, Copaxone, Novantrone and Rebif – approved in the U.S. for treating the major forms of MS. This approval provides additional treatment options for individuals with relapsing-remitting MS in the United States. Each of the approved treatments has pros and cons. The decision of which therapy is best for any individual should be determined in consultation with his or her personal physician.

More information about Rebif is available from the company – online at http://www.rebif.com, or by calling 1-877-44REBIF.

 
© 2002 The National Multiple Sclerosis Society