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FDA grants marketing approval to GSK’s diabetes drug based on Novozymes’ Veltis technology

GlaxoSmithKline (GSK) has received marketing approval from the US Food and Drug Administration (FDA) for its new type 2 diabetes drug, branded as Tanzeum in the US and Eperzan in Europe.

The new drug uses Novozymes’ Veltis technology to achieve an extended half-life that means patients are only required to inject their medication once a week.

The approval follows GSK’s announcement in March that albiglutide received marketing authorization in Europe.

Novozymes Biopharma marketing director Dermot Pearson said this is yet another important market approval for a drug based on the company’s Veltis technology.

"The versatile capabilities of our solution are being continually demonstrated by our customers," Pearson said.

"Not only has Novozymes developed a platform that helps medicines achieve optimum therapeutic effect, but that also improves the day-to-day management of conditions by extending drug half-life and, therefore, reducing the frequency at which patients need to inject."

Veltis is a half-life extension platform based on engineered albumins that allows manufacturers to define and optimize the therapeutic window of their drug candidate to control dose frequency, dose quantity and improve drug tolerability.

It also offers the Novozymes’ partners, such as the recently collaborated Janssen, the ability to provide once-weekly, once two-weekly or once-monthly peptide or protein dosing, and, as a result, offers the potential for enhanced patient compliance and improved therapeutic impact.