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CHMP backs trio of Novartis products

Including two diabetes drugs and one for non-cancerous kidney tumours

Novartis had a flurry of product approval recommendations from the EU's Committee for Medicinal Products for Human Use (CHMP) last week, including two diabetes drugs and one for non-cancerous kidney tumours.

The CHMP issued two positive opinions for Novartis' Galvus (vildagliptin) and combination product Eucras (vildagliptin plus metformin) when used in combination with other diabetes treatments, including a stable dose of insulin.

Galvus was also backed as an add-on therapy for diabetes patients who are currently being managed with a sulfonylurea plus metformin, said Novartis.

The new recommendations still have to be formally approved by the European Medicines Agency (EMA) but if this occurs they will "open the way for new treatment options for patients unable to reach their blood sugar goals", according to the pharma company.

The new indications could provide further momentum for Novartis' vildagliptin franchise, which is one of the fastest growing in the company's portfolio with sales of Galvus alone rising more than 50 per cent in the first half of this year to reach $425m.

Meanwhile, Novartis also received CHMP backing for Votubia (everolimus) its candidate drug for a form of kidney tumour called renal angiomyolipoma associated with the genetic disorder tuberous sclerosis complex (TSC).

TSC affects approximately one to two million people worldwide and is associated with a number of resulting disorders such as seizures and swelling in the brain.

If approved by the EMA, Votubia would become the first non-surgical treatment for the condition in the EU, although it was approved for this indication in the US in the second quarter of this year.

Votubia contains the same active ingredient as Novartis' cancer drug Afinitor, another of it's fastest-growing products with sales of $318m in the first half of the year, up 71 per cent year-on-year.

Votubia is already approved in the EU to treat non-cancerous brain tumours associated with TSC.

24th September 2012

From: Sales, Regulatory



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