EU approval for Ilaris
pharmafile | March 4, 2013 | News story | Sales and Marketing | Ilaris, Novartis
Novartis’ Ilaris has become the first biologic approved by the European Commission to treat patients suffering acute gouty arthritis attacks who cannot manage them on other treatments.
Ilaris (canakinumab) was launched in the UK three years ago as a treatment for cryopyrin-associated periodic syndrome, a rare auto-inflammatory disease.
Novartis has been seeking to extend the licence of this fully human monoclonal antibody targeting interleukin-1 beta (IL-1 beta). But its path in the US has been rocky: Novartis says it is continuing to work with the FDA to determine the next steps for the drug in this therapy area, after receiving Complete Response letter in August 2011.
The US regulator wanted additional clinical data in gouty arthritis – commonly referred to as gout – to evaluate the benefit/risk profile in refractory patients. An FDA advisory panel voted 11-1 against backing the drug because of safety concerns: trials showed patients receiving it were at a higher risk of serious infections.
However, European authorities have been convinced by the drug, which comes in a single, subcutaneous 150 mg injection and can be used after patients fail on drugs like ibuprofen or colchicine.
Ilaris is specifically indicated for patients who have had at least three attacks in the previous 12 months in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are not appropriate, or have not worked.
Gouty arthritis is a serious, chronic and progressive disease that affects one to four per cent of adults, and attacks happen when the body has a strong inflammatory response to uric acid crystals forming in the affected joint – usually in the toe, foot, ankle or knee.
The inflammation associated with the condition can cause severe pain and debilitating symptoms lasting more than a week and other treatments can be unsuitable for patients with serious comorbidities. These include hypertension, kidney disease, diabetes, dyslipidemia and cardiovascular disease.
“The approval of Ilaris for acute gouty arthritis attacks in patients without appropriate treatment options provides new hope for those debilitated by this excruciating condition,” said David Epstein, division head of Novartis Pharmaceuticals.
Two Phase III trials and their extensions showed patients experienced far greater pain relief on Ilaris compared to the injectable steroid triamcinolone acetonide (TA).
More than 450 patients were randomized to receive Ilaris 150 mg or TA 40 mg via intramuscular injection.
Pain intensity in the overall study population was statistically significantly lower for Ilaris compared to TA at 72 hours (-10.7 mm, p<0.0001), with an absolute mean decrease in VAS score (a recognised measure of pain relief) of approximately -50 mm.
Pain reduction was observed as early as six hours after dosing in both groups, with a statistically significant difference between treatments observed from 24 hours to 7 days – and Ilaris also reduced the risk of subsequent attacks.
Most adverse events were mild to moderate, with upper respiratory tract infections and nasopharyngitis the most common.
The EC also has also given Novartis an additional year of data exclusivity because of the ‘significant’ clinical benefit of Ilaris over existing treatments.
Adam Hill
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