Merck seeks additional Januvia approvals

Share this article:
Merck has filed applications with the FDA for two additional uses for its diabetes treatment Januvia. Merck is seeking approval for Januvia for the added indications as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycemic control; and as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea plus metformin when dual therapy does not provide adequate glycemic control. Januvia is currently approved for use as a monotherapy and as add-on therapy to either metformin or thiazolidinediones, to improve blood sugar control in patients with type 2 diabetes when diabetes when diet and exercise are not enough. Januvia was approved in October 2006. Fourth quarter sales of the drug came in at $42 million.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.