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FDA approves Merck's diabetes pill

Novel treatment expected to be blockbuster

The Food and Drug Administration this morning approved a novel way to treat diabetes that is quickly expected to become a billion dollar blockbuster.

Merck & Co.'s Januvia, a once-a-day pill to treat Type 2 diabetes, is the first in a new class of medicines that help lower blood sugar levels only when they are too high.

The FDA said Januvia can be used on its own, along with diet and exercise, to lower blood sugar or can be taken in combination with metformin or a PPAR agonist drug, short for peroxisome proliferator-activated receptor gamma. They are among the nation's most widely prescribed diabetes drugs.

Merck stock edged up on the approval, trading at $43.85, up .21 percent.

Some 21 million Americans, or 7 percent of the nation, are diabetics with blood sugar levels that are too high. Diabetes can cause blindness, kidney failure, heart ailments and can lead to amputations.

Januvia is the latest in a cascade of diabetes treatments that have raised optimism among physicians and patients seeking new ways to combat a disease that progressively worsens. The recent innovations have revolutionized diabetes care -- raising to nine the number of drug classes that doctors can prescribe to combat the disease.

So far, Januvia appears free of the side effects -- such as serious gastrointestinal problems and weight gain -- that are found in older diabetes therapies. Many fear that could change when millions begin to use the drug.

Analysts and physicians said Januvia offers "modest" reduction in a key value measured every three months to gauge how well people with diabetes are controlling blood sugar. The more elevated that value, the higher the risk for eye, kidney, nerve and heart damage.

A Boston man who has responded well to metformin for his Type 2 diabetes said he would welcome even a slight improvement in his blood sugar value.

"I look at it as almost like a scale," said Marc Onigman, 56. "If the drug can help me keep that number dead-even, bring on the drug. As long as it doesn't have side effects that lay me out for a week."

Januvia boosts insulin levels when needed, but not so much that blood sugar falls too low.

"The insulin comes when the blood sugar is high, but it shuts off when the blood sugar goes down to normal," said Dr. Edward Horton, director of clinical research at the Joslin Diabetes Center in Boston. "It’s taking advantage of the body's own mechanism to respond to a meal. We don't have any drugs that actually do that."

Horton, a Harvard Medical School professor of medicine, is a paid Merck consultant.

The enzyme targeted by Januvia is involved in metabolizing many of the body's hormones.

"The concern always has been that the regulation of some of those hormones may be very important in subsets of patients that we don't yet understand," said Dr. John Buse, director of the Diabetes Care Center at the University of North Carolina-Chapel Hill and president-elect of the American Diabetes Association.

"There are many patients and -- maybe, even more doctors -- who are relatively reluctant to use a new drug in the first six months or year after it’s released," Buse said. "There are so many options. And this isn't going to be the most powerful agent available."

About 95 percent of adults with diabetes have Type 2 diabetes, an ailment that has skyrocketed in recent years as obesity rates spiked among Americans, according to the National Institutes of Health. Some 400 different diabetes compounds are in development.

Deutsche Bank research analyst Barbara Ryan, in a recent note, called diabetes "hot, hot, hot" with a market size capable of supporting "multiple new blockbuster opportunities."

Novartis AG is hot on the heels of Januvia with its own new-generation diabetes pill, Galvus, expected to receive FDA approval this year.

Merck intends to launch Januvia "immediately after approval, taking advantage of a short window before Galvus gets the green light," Morgan Stanley analyst Jami Rubin wrote in a research note. Rubin forecasts $350 million in global Januvia sales in 2007 with $1.6 billion in sales by 2010, a conservative estimate.

Rubin also thinks Januvia and Galvus -- expected to be priced at $4 to $5 per day -- ultimately will wrest US market share from existing diabetes treatments that account for 66 million prescriptions per year.

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