Merck & Co says that the US Food and Drug Administration accepted for review two application for new indications for its promising new diabetes treatment Januvia.
The company noted that the first supplemental New Drug Application deals with the use of Januvia (sitagliptin), as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycaemic control. The other sNDA has been filed in support of two proposed new indications for use of the drug, again as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea when the single agent alone does not provide adequate glycaemic control and as add-on therapy to the combination of a sulfonylurea plus metformin when dual therapy does not provide adequate glycaemic control.
Januvia, the first in a new class of drugs called dipeptidyl peptidase-4 inhibitors, is currently indicated for use as monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve glucose control in patients with type 2 diabetes when diet and exercise are not enough.
Januvia is already approved to treat type 2 diabetes. The company is asking the FDA to add approvals for use as an initial and add-on therapy for glycemic control in combination with metformin. Merck said it expects a decision by mid-October.
John Amatruda, vice president of clinical research at Merck & Co, said if these sNDAs are approved, the expanded labelling 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 antihyperglycaemic agents." A decision is expected by mid-October.
The filings are supported by a 24-week study in 1,091 randomised patients with type 2 diabetes, the results of which were presented for the first time at the European Association for the Study of Diabetes in September 2006.
Merck ratings unaffected by large tax settlement
Meantime, Standard & Poor's Ratings Services says that Merck’s recent agreement with the IRS to settle all tax disputes for $2.3 billion does not have an impact on the ratings on the company or the rating outlook. The credit broker noted that while the settlement amount is significant, Merck had more than $15 billion in cash and investments at September 30, 2006, “and more importantly, the settlement removes a major uncertainty for the company.”