Sandoz says gets positive opinion from EMA committee on Omnitrope

By Lisa Kerner

Erie, Pa., Jan. 27 - Sandoz said the European Medicines Agency's Committee on Medicinal Products for Human Use issued a positive opinion regarding the company's recombinant human growth hormone Omnitrope.

In June 2003, the committee recommended that the European Commission grant marketing authorization for Omnitrope. The commission refused on legal grounds related to the selected approval pathway, according to a company news release.

Sandoz submitted a second application in July 2004, based on a recommendation from the European Medicines Agency and the commission.

Australia's Therapeutic Goods Administration approved Omnitrope in September 2004 for treatment of growth disorders in children. The product was launched in Australia in November 2005.

In August 2004, the Food and Drug Administration said it was unable to reach a decision on whether to approve the company's application for Omnitrope. Sandoz responded by filing a lawsuit against the FDA. That lawsuit is still pending, the company said.

"With Omnitrope's positive status in Europe, we now hope the FDA will finally move in granting a marketing authorization for the United States, acknowledging the sound science that supports this product," chief executive officer Dr. Andreas Rummelt said in the release.

Sandoz, a division of the Novartis group, is a generic pharmaceutical company with its headquarters in Holzkirchen, Germany.

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