The FINANCIAL -- Novartis announced that the Committee for Medicinal Products
for Human Use of the European Medicines Agency has adopted a
positive opinion for the use of llaris in the
treatment of patients with acute gouty arthritis who suffer frequent
attacks, and whose symptoms cannot or should not be managed with current
"Novartis welcomes the decision by the CHMP in support of the approval of Ilaris in the EU," said David Epstein, Division Head of Novartis Pharmaceuticals. "When approved, lIaris will provide a new treatment option for patients who have endured frequent and crippling gouty arthritis attacks and where existing therapies do not offer relief. We look forward to receiving the final decision from the European Commission in the coming months."
Ilaris is the only available fully human monoclonal antibody that specifically targets IL-1 beta and, when approved, will offer patients suffering gouty arthritis attacks rapid pain relief via a single subcutaneous injection of 150 mg.
Gouty arthritis, commonly referred to as gout, is a serious, chronic and progressive inflammatory disease that generally affects 1 to 4% of adults. Gouty arthritis is associated with a high prevalence of comorbidities, such as hypertension, kidney disease, diabetes, dyslipidemia and cardiovascular disease. As Novartis said, these conditions can lead to contraindications for existing therapies and complications for disease management.
When approved, Ilaris will be specifically indicated for the 'symptomatic treatment of adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate'. Since urate lowering therapy (ULT) is generally advised in these patients, Ilaris may provide sufficient pain relief to allow initiation or continuation of ULT.
Data from two Phase III trials and their extensions, which informed the CHMP's positive opinion for Ilaris in gouty arthritis, 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, with infections being the most frequent of them.
The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation.