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Januvia gains renal impairment licence in UK

Published on 13/04/12 at 11:42am

Merck’s Januvia has had its licence extended in the UK for patients with moderate to severe renal impairment.

The drug is already one of the biggest selling diabetes pills in the world, achieving global sales of $3.3 billion last year.

Januvia (sitagliptin) is the leader in the DPP-4 inhibitor class, a new generation of oral diabetes treatments.

Many diabetes patients have renal impairment, making drug treatment of the diabetes more difficult, with some medicines contraindicated in these patients. Januvia has been one of these contraindicated treatments until now, but lower dose forms of the drug can now be used in these patients in the UK.

Professor John Wilding, head of the department of obesity and endocrinology at the University of Liverpool, said: “One of the main complications of diabetes is kidney disease, or diabetic nephropathy, and this unfortunately develops in up to one third of all people with diabetes.

“Treatment choices for glucose-lowering treatments are limited because some drugs cannot be used in people with kidney disease, or may increase the risk of hypoglycaemia.

“Physicians around the world have been prescribing sitagliptin at 25mg and 50mg in this large patient population for a number of years, so it is pleasing that in the UK we now have the option for dosage adjustment to improve glycaemic control, in renally compromised patients with a low risk of hypoglycaemia,” he added.

This opens up the drug to more diabetes patients, which is likely to help its already strong growth in the UK.

GP prescribing data shows spending on the drug in England jumped from £27 million in 2010 to £45 million last year. This was the biggest increase in spend of any new drug, putting it on track to be a big earner for MSD (Merck) in the UK.

The update means Januvia has the same licence as Boehringer’s rival DPP-IV diabetes treatment Trajenta, launched in the UK last September.

Trajenta (linagliptin) is also licensed in type II patients with renal impairment, and works in much the same way as Januvia.

Januvia’s new licence will help it maintain its lead in the DPP-IV diabetes market, in which Novartis’ Galvus (vildagliptin) is another competitor.   


Ben Adams

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