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Actelion withdraws Zavesca bid


Drug manufacturer Actelion has withdrawn its application to the European Medicines Agency (EMEA) for an extension of the medicine Zavesca (miglustat).

Zavesca was expected to be used for the treatment of neurological problems in patients with Niemann Pick type C disease, a rare inherited condition that affects children and teenagers.

Zavesca was first authorised in the European Union on 20 November 2002 to treat mild to moderate type 1 Gaucher disease.

Symptoms of the disorder can include an enlarged liver and spleen, anaemia, thrombocytopenia, lung disease, and arthritis.

Zavesca may only be used in the treatment of patients for whom enzyme replacement therapy is unsuitable.

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An application for the extension of the indication for Zavesca was submitted to the EMEA on 16 October 2006.

The agency’s Committee for Medicinal Products for Human Use (CHMP) recommended refusing the type II variation on 18 October 2007.

Actelion then requested this decision was re-examined, but the company withdrew the application before this could be completed.

In its official letter, the company stated it is ending its extension bid after discussions with the CHMP regarding the need for additional data from patients treated with Zavesca in a clinical setting.

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