GlaxoSmithKline receives CHMP recommendation for diabetes drug approval

GlaxoSmithKline's new diabetes drug Eperzan has been recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has endorsed the use of the product as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes, either as a monotherapy or in combination with with other glucose-lowering medicinal products.

A comprehensive global programme of studies involving over 5,000 patients, encompassing a total of eight phase III trials, has provided a robust body of evidence showing the safety and efficacy of the drug.

A final decision from the European Commission on marketing authorisation is anticipated during the first quarter of 2014.

Dr Carlo Russo, senior vice-president, research and development at GlaxoSmithKline, said: "Today's positive opinion is a major milestone towards offering people with uncontrolled type 2 diabetes a new option to help manage their condition."

This comes after the company launched Relvar Ellipta, a new once-daily inhaler treatment for asthma and chronic obstructive pulmonary disease, in the UK earlier this month.