MSD’s Januvia accepted for review

The US Food and Drug Administration has accepted two additional supplemental new drug applications (sNDAs) for MSD’s Januvia (sitagliptin), with a decision expected by mid-October.

Currently indicated for use as a monotherapy, Januvia also works as an add-on to either of two other types of oral diabetes medications, metformin or thiazolidinediones, improving glucose control in patients with type two diabetes who cannot control their blood sugar through diet and exercise alone.

Of the new sNDAs, one proposes the use of Januvia as an adjunct to diet and exercise, used in combination with metformin, while the second recommends the therapy as an additional therapy to a sulfonylurea and or sulfonylurea plus metformin.

“If these sNDAs are approved, the expanded labeling will include indications for use of Januvia as initial therapy with metformin and as add-on to any of the three most commonly prescribed classes of oral antihyperglycemic agents,” said John Amatruda, vice-president of clinical research at MSD.

“These data further support the broad utility of Januvia as an important treatment option for patients with type two diabetes,” he added.

Separately, MSD recently announced that its has updated the prescribing information for Rotateq, its vaccine to help prevent rotavirus gastroenteritis in infants.