Swiss pharmaceutical giant Novartis AG (NVS) Friday said the European Commission approved Ilaris for the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.
Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication. It is administered in a single, subcutaneous injection of 150 mg.
The EC also granted an additional year of data exclusivity to Novartis based on the clinical benefit over existing treatments demonstrated for the drug.
Gouty arthritis, commonly referred to as gout, is a chronic and progressive inflammatory disease that affects 1 percent to 4 percent of adults.
Ilaris is specifically indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks, which is at least 3 attacks in the previous 12 months, in whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, not tolerated, or do not provide an adequate response. Repeated courses of corticosteroids are not appropriate for this patient population.
Data from two Phase III trials and their extensions supported the EU approval for Ilaris. These data showed that patients treated with Ilaris experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide.
The majority of adverse events were mild to moderate, and infections like upper respiratory tract infections and nasopharyngitis were the most frequent of them.
The stock added 1.9 percent on Thursday to close at 63.65 Swiss francs.
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