Tuesday, July 26, 2011

Indacterol Approved for COPD

Indacaterol was approved by the U.S. F.D.A. for the treatment of COPD on 7/1/11.  The trade name is Arcapta Neohaler (photo).  In Europe, the trade name is Onbrez (photo).  Functionly, the delivery device is essentially the same as Foradil's delivery device.  This should not too surprising, since Foradil was originally a product from the same manufacturer - Novartis.  Indacaterol is a once-daily long-acting bronchodilating agent (LABA), which puts it in the same class of drugs including formoterol (Foradil) and salmeterol (Serevent).  Recent controversy regarding the safety of LABAs for asthmatics has stalled Novartis' efforts to get Indacaterol approved for asthma.  Novartis has optioned Indacaterol's rights for asthma to another pharmaceutical company, however then it will be that company's burden to satisfy the FDA's safety concerns with LABA (see prior posts), before the FDA grants approval.  This could be lengthy and definitely expensive hurdle.  The Allergy Dude predicts that it will be quite some time until Indacaterol is approved in any product for asthma.

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