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FDA Seeks More Information From Novartis

October 20, 2009

The US Food and Drug Administration on Monday requested additional information on dosing for an experimental smoker’s cough treatment being developed by Swiss drug maker Novartis.

Novartis said it would be working with the FDA to disclose information about the experimental drug, known as QAB149 or indacaterol, to determine if clinical trials would be required.

The announcement marks a minor setback for the company in the development of indacaterol, which is being marketed as the first bronchodilator treatment for adult patients with chronic obstructive pulmonary disease (COPD).

According to the Wall Street Journal, the drug will be marketed in Europe under the name Onbrez Breezhaler. The drug has been recommended for approval by the FDA’s counterpart in Europe.

“We think Novartis’ attempts to build a respiratory franchise will only bear fruit once combination data and products are in the market, something that will not happen for many years,” Kepler Capital Markets analyst Tero Weckroth told Reuters.

“From this point of view, a delay for QAB does not have a major impact on numbers,” he added.

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