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Biogen Avonex May 17 approval allowed under orphan regs based on lack of injection-site necrosis, FDA says.

Executive Summary

BIOGEN AVONEX APPROVAL ALLOWED BY LACK OF INJECTION-SITE NECROSIS seen with Berlex/Chiron's Betaseron (interferon beta-1b), FDA said in approving the Biogen multiple sclerosis product. In a May 18 "Talk Paper," FDA said that "this new product has been allowed to enter the market because it differs from interferon beta-1b based on an absence of reports of injection site necrosis." FDA does not indicate whether the molecular difference of one amino acid between the products played a role in its decision to allow Avonex on the market despite Chiron's orphan exclusivity for Betaseron.

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