FDA requests additional data for Novartis' COPD drug indacaterol

Novartis announced Monday that it received a complete response letter from the FDA regarding its filing for the experimental drug indacaterol, in the treatment of adults with chronic obstructive pulmonary disease (COPD). The agency requested additional information on the proposed dosing for the once-daily bronchodilator.

Commenting on the news, Kepler Capital Markets analyst Tero Weckroth remarked that "we think Novartis' attempts to build a respiratory franchise will only bear fruit once combination data and products are on the market, something that will not happen for many years." Analyst Sam Fazeli said that he and fellow analysts at Piper Jaffray "are confident that Novartis will be able to address the FDA's dosing concerns...particularly in view of the product's recent [positive opinion]" from the European Medicines Agency's Committee for Medicinal Products for Human Use.

The drugmaker stated that it will work with the FDA "to review already submitted data for [indacaterol] as well as recently available data to determine what, if any, further clinical trials would be required."

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