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Merck's diabetes drug Januvia gets FDA approval
The Food and Drug Administration said Tuesday that it approved Merck & Co.'s
(MRK) drug Januvia to treat type 2 diabetes.
Januvia is the first in a new class of diabetes medicine known as DPP-4 inhibitor. The drug works by enhancing the body's own ability to lower blood sugar, or glucose, when it is elevated.
Swiss-based Novartis AG (NVS) has a similar drug, Galvus, which is also awaiting FDA approval.
Analysts have predicted both drugs could easily reach blockbuster status of more than $1 billion in annual sales by 2010 as long as no major safety issues emerge.
About 21 million people in the U.S. have diabetes, a disease that is characterized by high blood glucose levels that result from the body's inability to use insulin.
Type 2 diabetes is the more common form of the disease and most often occurs in people who are older than 45 and overweight, although there's been an increase in younger patients in recent years. Type 1 diabetes, often diagnosed in childhood, requires people to use insulin to manage their blood sugar levels. Many diabetics also have poor lipid profiles, which also puts them at risk for cardiovascular disease. Diabetes can also lead to blindness, kidney disease and amputations.
DPP-4 inhibitors work in a different manner than blood-glucose lowering drugs currently on the market, including sulfonylurea drugs, which stimulate the pancreas to release insulin, and metformin, which works on the liver to reduce blood sugar.
Two other drugs on the market, Actos by Takeda Pharmaceuticals North America Inc. and Eli Lilly & Co. (LLY) and Avandia by GlaxoSmithKline PLC (GSK), make the body more sensitive to insulin.
Because of the drugs' differing effects to lower blood sugar, many of them are combined in treatments.
The FDA approved Januvia for use in addition to diet and exercise, alone or in combination with metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
According to Dr. John Amatruda, vice president of clinical research for Merck, the drug's label will also reflect that its side-effect profile is similar to placebo, or fake pill.
Those side effects include runny nose, sore throat, upper respiratory tract infection and diarrhea. Unlike current diabetes drugs on the market, DPP-4 inhibitors don't cause weight gain, which is seen as a major benefit, as the majority of diabetes type 2 patients are already overweight or obese.
"We now have an option for physicians of a new and novel drug which has powerful glucose lowering efficacy without causing many of the side effects of current agents," Amatruda said. "And it can be used both alone and in combination."
Merck, however, will likely have to share the market of DPP-4 inhibitors with Novartis, which is set to hear from the FDA on Galvus next month.
Representatives for both Merck and Novartis declined to draw comparisons between the two drugs, saying they haven't been studied head-to-head.
"If there are other products that get approved at some point in the future, that only reinforces the fact that we believe that this class of drugs, DPP-4 inhibitors, is a major advance for the treatment of this disease," said Jay Galeota, general manager of Merck's global diabetes franchise.
Januvia is already approved in Mexico. "With the U.S., and other
countries soon to follow, we expect to have a rollout globally over the near
future," Galeota said.
Shares of Merck closed Monday at $43.76 each, up 56 cents, while Novartis stock closed at $57.54, up 45 cents.
Forbes had the following snipit in their highlights for today:
FDA Approves New Diabetes Drug
A new drug to treat type 2 diabetes was
approved Tuesday by the U.S. Food and Drug Administration.
Januvia (sitagliptin phosphate) is unlike any other oral drug for people with
type 2 diabetes. It's designed to enhance the body's own ability to lower blood
sugar levels. Clinical trials found that the drug works as well as older
diabetes drugs, but causes fewer side effects such as weight gain, the
Associated Press reported.
Januvia, which is made by Merck & Co., is
expected to cost between $3 and $6 a day. Some older diabetes drugs cost 50
cents a day.
The new drug works by increasing levels of a hormone that
tells the pancreas to produce more insulin to process blood sugar and also
instructs the liver to stop making glucose. Januvia does this by blocking
production of an enzyme (DPP-4) that inactivates this hormone, the AP reported.
"For the millions of Americans with type 2 diabetes, who continue to
have inadequate blood sugar control, the approval of Januvia marks an important
advance in the fight against diabetes," said Dr. Steven Galson, director of the
FDA's Center for Drug Evaluation and Research.
"We now have another new
option that treats the disease in an entirely new way that can be added to
existing treatment regimens to help patients gain more control over their blood
sugar levels," Galson said.
About 20 million Americans have type 2
In any case, it sounds like good news for type 2 sufferers.