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Home Industry News Novartis receives response from FDA on approval of QAB149

Novartis receives response from FDA on approval of QAB149

19th October 2009

Novartis has been issued with a response to its request for the approval of its investigational bronchodilator for COPD, QAB149 (indacaterol).

The Food and Drug Administration (FDA) has requested additional information on recommended dosing before it approves the treatment, Novartis has revealed.

Trevor Mundel, global head of development at Novartis, commented: “Our confidence in the benefit/risk profile of QAB149 is based on results of phase III trials which showed QAB149 significantly improved lung function in patients with this severe disease.”

He added that the firm will continue to work with the FDA for the authorisation of the treatment and the possible conducting of further clinical trials into the drug.

In other Novartis news, the firm was last week granted the exclusive rights to market the schizophrenia drug Fanapt (iloperidone), from Vanda Pharmaceuticals.

Fanapt is an antipsychotic therapy that is scheduled to be launched in early 2010.

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