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Home Industry News Actelion to act on FDA response letter over Zavesca

Actelion to act on FDA response letter over Zavesca

10th March 2010

Actelion has committed to working together with the Food and Drug Administration (FDA) in order to fulfil its criteria over the approval of Niemann-Pick type C (NP-C) disease drug Zavesca.

The pharmaceutical company has received a complete response letter from the regulator in relation to its supplemental new drug application for the Zavesca treatment.

It states that Actelion must supply additional clinical and preclinical information on the drug to the FDA before it can be approved as a treatment for progressive neurological manifestations in adult and paediatric sufferers of NP-C disease.

As a result, the company has stated that it will be looking to “work diligently” to meet the FDA’s requirements.

Dr Jean-Paul Clozel, chief executive officer of Actelion, added: “We remain committed to bringing an approved treatment to patients suffering from NP-C disease and in this spirit we will continue the dialogue with the FDA.”

Last month, the healthcare firm published its financial report for 2009, during which it experienced an increase in terms of its revenues and sales.

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