Copaxone stay rejected and balugrastim withdrawn

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Copaxone stay rejected and balugrastim withdrawn

Biosimilars/General | Posted 06/12/2013 0 Post your comment

Teva Pharmaceutical Industries (Teva) had its request for a stay of an appeals court ruling on its blockbuster drug Copaxone (glatiramer acetate) rejected, and that it had withdrawn its application for approval of balugrastim (granulocyte colony-stimulating factor [G-CSF]).

On 13 November 2013, US Supreme Court Chief Justice John Roberts declined a request from Teva for a stay of an appeals court ruling made in July 2013 that invalidated several of Teva’s patents on Copaxone, including one that protected the drug until September 2015. The decision opened Teva’s blockbuster multiple sclerosis drug to competition from generics starting in May 2014 [1].

Teva had asked the US Supreme Court to stay the ruling while the company prepares to file a petition seeking the high court’s review, but the court announced that Chief Justice John Roberts had rejected the request and did not provide further explanation.

On 18 November 2013, Teva announced that it had withdrawn its balugrastim Biologic License Application (BLA) from the US Food and Drug Administration (FDA) review process following ongoing consultation with the agency. Teva said that FDA has agreed to work with the company in designing any additional studies that may be required in support of the BLA for balugrastim.

Balugrastim has been evaluated in phase III clinical trials for its ability to reduce the duration of severe neutropenia in breast cancer patients undergoing chemotherapy. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections. The drug is seen as comparable, and therefore a potential competitor, to Amgen’s Neulasta (pegfilgrastim).

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Teva loses fight against generic glatiramer acetate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 6]. Available from: www.gabionline.net/Generics/News/Teva-loses-fight-against-generic-glatiramer-acetate

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Source: Reuters