FDA Rejects Concentrated Copaxone
NEW YORK (AP) - Teva Pharmaceutical Industries Ltd. said the Food and Drug Administration declined to approve a more concentrated version of its drug Copaxone, a treatment for multiple sclerosis.
Teva said the FDA might require it to run a new clinical trial to show the new version works as well as the one that is already on the market. The approved version of Copaxone contains 20 milligrams of glatiramer acetate, the active ingredient in the drug, in one milliliter of solution. Teva is trying to get approval for a version that contains 20 milligrams of glatiramer acetate in half a milliliter of solution.
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.
Multiple sclerosis is an autoimmune disease in which the body's immune system attacks a protective lining on the nerves. Teva says Copaxone is the most-prescribed MS drug in the world. In the first nine months of 2010, Teva reported $2.38 billion in sales of Copaxone. Teva, the world's largest maker of generic drugs, is working on other MS therapies.
Date: December 23, 2010
Source: Associated Press