Merck Wins FDA Approval for Diabetes Drug
PHILADELPHIA _ Merck & Co. Inc. said Monday federal regulators have approved a new pill for Type 2 diabetes combining its drug Januvia with the current No. 1 treatment, metformin.
Merck’s new pill, called Janumet, is meant to be more convenient for certain patients while capturing for Merck part of the market for metformin, a generic treatment. Its benefit over current treatments is said to be fewer side effects and less weight gain, although it still carries several precautions and warnings.
The list price of Janumet, a twice-a-day medication, will be $4.86 per day, Merck said. That is roughly the same price Merck put on Januvia alone when it was approved in January.
In a note to investors this morning, David Risinger of Merrill Lynch said approval likely will ensure a steady increase in diabetes-treatment revenues for Merck.
He said a Merrill Lynch-commissioned survey of physicians found nearly all who have tried Januvia were satisfied, and he predicted Janumet eventually could “match” sales of top branded treatments Actos, made by Takeda Pharmaceuticals North America Inc., and Avandia made by GlaxoSmithKline P.L.C.
Shares in Merck this morning were at $44.89, up 72 cents or 1.6 percent. Merck is headquartered in Whitehouse Station, N.J. and has its biggest operation in Montgomery County, Pa.
Januvia and Janumet both are in a class of new diabetes treatments calls dipeptidyl peptidase-4 inhibitors, or DPP-4 inhibitors.
Merck said the Food and Drug Administration approved Janumet “as an adjunct to diet and exercise, to improve blood sugar (glucose) control in adult patients with type 2 diabetes who are not adequately controlled on metformin or Januvia alone, or in patients already being treated with the combination of Januvia and metformin.”
Janumet puts Merck even further ahead of Novartis AG, which has not yet received FDA approval of its own DPP-4 inhibitor, Galvus.
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