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Gilead's hepatitis B virus treatment set for European approval

CHMP also recommends diabetes drugs from Sanofi and Novo Nordisk

Gilead SciencesGilead Sciences' once-daily chronic hepatitis B virus (HBV) therapy Vemlidy has been recommended for the treatment of adults and adolescents by the Committee for Medicinal Products for Human Use (CHMP).

The EMA advisors issued a positive opinion for Vemlidy (tenofovir alafenamide) after data from two phase III studies showed Vemlidy to be superior to its predecessor Viread (tenofovir disproxil) in both previously treated and treatment-naïve HBV patients.

Due to TAF's greater plasma stability, Vemlidy can be administered at one-tenth of the dose of Viread, reducing the levels of tenfovir in the bloodstream, and yet matches the older drug for efficacy and improves patients' renal and bone safety.

The CHMP's recommendation follows the drug's recent approval by the FDA, which licensed Vemlidy for adults with chronic HBV and compensated liver disease last week.

New diabetes drugs backed
Also among the new medicines endorsed for European approval this month are diabetes treatments Suliqua and Fiasp, from Sanofi and Novo Nordisk, respectively.

Suliqua, an insulin glargine and lixisenatide combination therapy, has been backed for the treatment of adults with type 2 diabetes.

The dual-therapy works to reduce high blood glucose while enhancing glucose-dependent insulin secretion and reducing glucagon release.

Backed for use in patients for whom metformin does not provide sufficient glycaemic control, Suliqua will be available as a once-daily add-on treatment option.

Sanofi's lixisenatide-only drug Lyxumia has been on the market in Europe since 2013 and was approved in the US by the FDA as Adlyxin in July this year.

Meanwhile, Novo Nordisk looks set to add Fiasp (insulin aspart) to its diabetes drug stable, as the fast-acting insulin analogue gets one step closer to European approval.

The injected treatment controls blood glucose by facilitating the uptake of glucose into skeletal muscle and fat tissue and inhibiting the liver's output, working faster than human insulin.

Despite having displaced Sanofi to become the global diabetes sales leader in 2015, Novo Nordisk is still feeling the effects of the highly competitive diabetes market and is in the process of slimming down its R&D units in Denmark, where 1,000 jobs on the line.

Article by
Rebecca Clifford

16th November 2016

From: Regulatory



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