Novartis announced Monday that the FDA issued a complete response letter regarding the company's application for approval of Ilaris (canakinumab) in patients with gouty arthritis. The company said US regulators requested additional information, including clinical data on the benefit-risk profile in refractory patients.

The application, which was submitted for review in the US in the first quarter of this year, was based on data from two late-stage trials demonstrating that patients with gouty arthritis who took the drug during an attack experienced superior pain relief at 72 hours, compared with patients given the injectable steroid triamcinolone acetonide.

Patients given Novartis’ drug also experienced a significant reduction in the risk of new attacks over six months compared to triamcinolone acetonide, the drugmaker noted.

Novartis said Ilaris was generally well tolerated in the trials, but noted that adverse events, including infections, were reported more frequently among patients given the experimental drug, compared with those administered the injectable steroid. In June, an FDA advisory panel recommended against approving Ilaris to treat gout attacks due to concerns about potential side effects.

The drugmaker also indicated Monday that it remains committed to evaluating Ilaris in inflammatory diseases where interleukin-1 beta plays a key role.


(Ref: Novartis, CNBC, FinanzNachrichten)