Teva says FDA won’t approve new version of Copaxone

The Jerusalem-based company received a complete response letter, which means the FDA informed the company it is not willing to approve the drug at this time. Teva said it will work with the FDA to determine its next steps. According to Teva, the FDA said it is not completely clear how Copaxone works, so the agency cannot be certain the new version would be as effective.

• Caroline says: The FDA has declined to approve a new formulation of Copaxone for RRMS. The currently approved injectable dose is 20 mg of glatiramer acetate in one milliliter of solution, and Teva is trying for 20 mg of glatiramer acetate in half a milliliter of solution (read: more side effects). Teva may need to run an additional clinical trial showing the new version works as well as the old version.
   

• Related Links:
• http://www.bloomberg.com/news/2010-12-23/teva-says-fda-won-t-approve-new-version…

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