The US Food and Drug Administration (FDA) has granted marketing approval to GlaxoSmithKline's new type 2 diabetes drug, branded Tanzeum in the US and Eperzan in Europe, which uses Novozymes' Veltis technology to achieve an extended half-life that means patients are only required to inject their medication once a week. The FDA approval follows GlaxoSmithKline's announcement in March that albiglutide received marketing authorization in Europe.
"This is yet another important market approval for a drug based on Novozymes' Veltis technology", says Dermot Pearson, marketing director, Novozymes Biopharma. “The versatile capabilities of our solution are being continually demonstrated by our customers. 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 enables manufacturers to define and optimize the therapeutic window of their drug candidate to control dose frequency, dose quantity and improve drug tolerability. The platform also offers Novozymes' partners, such as the recently announced collaboration with 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.
The market approvals for albiglutide do not impact Novozymes’ financial outlook for 2014.
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