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EMA committee recommends 2 Novartis drugs for EU approval

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EMA committee recommends 2 Novartis drugs for EU approval

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Novartis AG's Ilaris in Europe for the treatment of three rare periodic fever syndromes.

Ilaris was recommended for approval for the treatment of tumor necrosis factor-receptor associated periodic syndrome, hyperimmunoglobulin D syndrome and familial Mediterranean fever. These can cause disabling and persistent fevers, which may be accompanied by joint pain, swelling, muscle pain and skin rashes with complications that can be life-threatening.

The committee's recommendation is based on results from a phase 3 trial that showed rapid and sustained disease control with the drug compared to placebo. Ilaris will be the first and only approved biologic treatment for these diseases in Europe, if approved.

In September, the U.S. FDA previously granted three simultaneous approvals of Ilaris for the treatment of these three conditions. The European Commission approved the drug for a license extension in August to treat patients with adult-onset Still's disease, a rare type of inflammatory arthritis.

Ilaris is currently approved and marketed for the treatment of systemic juvenile idiopathic arthritis in the U.S. and EU and for the treatment of adult-onset Still's disease and the symptomatic treatment of refractory acute gouty arthritis in the EU. It is also approved in more than 70 countries for the treatment of cryopyrin-associated periodic syndromes.

In addition, the committee recommended the approval of the company's Votubia as an adjunctive treatment for patients aged two years and older with refractory partial-onset seizures related to tuberous sclerosis complex, a rare genetic disorder that may cause benign tumors to form in vital organs, as well as certain other disorders.

Votubia's recommendation is based on efficacy and safety data from a phase 3 study, which showed that the drug significantly reduced refractory partial-onset seizures associated with tuberous sclerosis complex compared to placebo. The drug has an orphan designation for the disease in Europe.