MSD gains FDA approval for Januvia expanded labelling

Merck, Sharp and Dohme has seen its Januvia inhibitor receive approval for expanded labelling from the US Food and Drug Administration (FDA).

The FDA has approved the Supplemental Drug Applications for Januvia (sitagliptin), a DPP-4 inhibitor for the treatment of type two diabetes which aims to improve glycemic control in adult patients.

MSD confirmed that the updating labelling will see Januvia indicated in a series of new combinations including in initial therapy with metformin.

It is also indicted as an add-on therapy to sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control and as an add-on therapy to the combination of a sulfonylurea and metformin when dual therapy does not provide adequate glycemic control

The FDA’s decision follows the release of new data contained in three studies supporting the efficacy and safety of Januvia.

Expanding labelling for Januvia also included warnings and precautions, which included post-marketing reports of hypersensitivity reactions in patients treated with Januvia.

Since its initial approval in October 2006, over two million prescriptions have been written for the type two diabetes inhibitor.

In March 2007, MSD announced that Januvia had been granted marketing authorisation by the European commission as a combination treatment with metformin for patients with type two diabetes to enhance control of blood sugar.