Novartis AG said the U.S. Food and Drug Administration rejected its anti-inflammatory drug canakinumab as a treatment to reduce the risk of heart disease.
The Swiss drugmaker said in its Oct. 18 earnings release that it received a complete response letter from the FDA in October regarding its application, adding that it is evaluating the agency's feedback.
Novartis already markets canakinumab as Ilaris in the U.S. to treat systemic juvenile idiopathic arthritis, an inflammation of the body that affects children, as well as a group of rare autoinflammatory diseases called cryopyrin-associated periodic syndromes.
Results from a phase 3 study, called Cantos, involving 10,061 people, showed that the drug, when used with the current standard of care, reduced the risk of another cardiovascular event, such as a heart attack or stroke, in patients who had survived heart attacks.
Novartis had gained nonexclusive licenses for canakinumab from Emeryville, Calif.-based XOMA Corp. in 2017 to market the drug to treat cardiovascular disease and other diseases and conditions.