FDA staffers want to know if the higher dose of Novartis' potential blockbuster COPD treatment indacaterol is necessary, according to documents released by the agency today. The FDA will ask an outside panel of experts to weigh the risks and benefits of the higher 150 microgram dose of the drug.
The long-acting beta agonist (LABA) represents a potential blockbuster opportunity for the Swiss drugmaker, which needs a fresh stream of revenue to replace sales that will be lost when the company's bestselling heart drug Diovan and cancer treatment Femara go off-patent. "Approval of [indacaterol] is an important stepping stone in Novartis' ambitions to launch a respiratory platform based on both single and combination therapies," Nomura analyst Amit Roy told Dow Jones.
A quick approval of the drug would give Novartis a nice head start over GlaxoSmithKline, which recently started a Phase III trial of its own version of the drug. The two drugmakers will be duking it out for access to the $20 billion COPD market.