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Home Industry News Novartis receives CHMP backing for Votubia and Ilaris

Novartis receives CHMP backing for Votubia and Ilaris

21st December 2016

Novartis has announced that two of its drugs have been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The positive opinion for Votubia has recommended the dispersible tablets as an adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).

If the European Commission chooses to approve the drug, it would be the first pharmacologic treatment approved specifically for the treatment of refractory seizures associated with TSC, meaning it will address an unmet medical need.

Meanwhile, Ilaris has been recommended by the CHMP to treat three rare and distinct periodic fever syndromes, which mostly affect children and cause recurrent and disabling fevers with potentially deadly complications.

The company is seeking approval for the drug in the treatment of tumour necrosis factor-receptor associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency, and familial mediterranean fever.

If approved, it will be the first and only biologic treatment in Europe for these three conditions.

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