Novartis is facing what could be a serious setback on one of its most promising drug candidates. The FDA said today that it will need to see more information on dosing before it can approve indacaterol, a COPD drug which is viewed as one of Novartis' most important late-stage prospects.
Novartis, which has pegged prospective sales of the drug, a once-daily bronchodilator also known as QAB149, at more than a billion dollars a year, says it will work with the FDA to satisfy its request and determine if a new clinical trial is necessary. A new trial would seriously delay the drug's market entry in the U.S. The drug has been recommended for approval in Europe.
Analysts say that Novartis won't achieve peak sales of the drug until it can be used in combination with other therapies.