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Glatiramer acetate

Copaxone

Teva Marion Partners

RRMS

Blocks myelin-specific autoimmune responses. Non-steroidal, non-interferon. Mechanism uncertain, but it is thought that glatiramer acetate, consisting of the acetate salts of synthetic polypeptides, resembles myelin basic protein (mbp) and serves as a decoy that blocks myelin damaging T cells.

Redness, pain and swelling and discoloration at injection site, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness, Immediate postinjection reaction characterized by chest tightness with heart palpitations and difficulty breathing



Note: Avonex, Betaseron, Copaxone, and Rebif are “orphan drugs.” The 1983 Orphan Drug Act (ODA) provides incentives for sponsors to develop products for rare diseases or conditions, by guaranteeing the developer of an orphan product seven years of market exclusivity following the approval of the product by the FDA. The definition of “rare disease or condition” in the Orphan Drug Act: “...the term rare disease or condition means any disease or condition which (a) affects less than 200,000 persons in the U.S. or (b) affects more than 200,000 persons in the U.S. but for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will be recovered from sales in the U.S. of such a drug.”

aRebif has been approved by the European Commission for the treatment of relapsing-remitting multiple sclerosis. The FDA has upheld the Orphan Drug Act and has not granted approval to Rebif. The FDA also had questions about the data filed in the marketing application, which prevented granting tentative approval. If tentative approval is received, Rebif could enter the US market in 2003, when the exclusivity periods for Avonex and Betaseron end.


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