FDA rejection of lower-dose Copaxone will likely ward off generic competition

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

In its response to Teva, the FDA noted that it could not approve the application for a lower-dose from of Copaxone as the drug’s mechanism was not fully understood. "Unless you can provide a convincing argument that the new higher concentration/lower volume formulation does not have an impact on efficacy, an adequate and well-controlled efficacy study will be needed to support efficacy of this new formulation," the FDA noted.

“This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound,” the company noted.

"The FDA's letter highlighted the high hurdle potential generic manufacturers of Copaxone face in gaining approval," JP Morgan analyst Chris Schott noted in a Dec. 23 research note.

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