By Thomas Ginsberg
INQUIRER STAFF WRITER
Oct. 17, 2006.
Federal regulators approved a new diabetes drug today with two kinds of beneficiaries: millions of people struggling to control their disease, and the drug giant Merck & Co. Inc. laboring to revive its fortunes.
The drug Januvia - a name made up by Merck marketers and meant to convey rejuvenation - is the first approved in a class known as DPP-4 inhibitors. Unlike insulin therapy, the new drugs work by enhancing the body's own ability to lower blood-sugar levels.
On Merck's heels, Switzerland-based Novartis AG expects approval soon of its own DPP-4 inhibitor, Galvus, also designed for people with Type 2 diabetes, the most common form. Both drugs are believed to have similar effectiveness and side-effect profiles, including minimal weight gain, although experts noted that neither has undergone long-term safety tests.
Robert Meyer, director of the U.S. Food and Drug Administration, described Januvia as a "welcome addition" to the oral medications already available for people who are not candidates for insulin.
Meyer noted that there was no evidence yet that DPP-4 drugs will be more effective than older drugs, but added: "Not everybody can tolerate each medication. So having a new drug is important in its own right."
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The FDA approved Januvia for use by itself or in combination with other oral drugs:
metformin, a generic treatment currently the No. 1 prescribed diabetes medication, or drugs known as TZDs, such as GlaxoSmithKline P.L.C.'s Avandia and Actos, made by Takeda Pharmaceuticals North America Inc.
"I think [the DPP-4 class] is going to play more into early, aggressive treatments," said Kelly L. Close, an industry-watcher and editor of the newsletter Diabetes Close Up. "So many patients have zero incentive to take their treatment, because the drugs prompt stomach problems, weight gain, hypoglycemia, edema, etcetera."
John Buse, vice president of medicine and science at the diabetes association, said the DPP-4 inhibitors would give physicians another tool for getting patients' blood sugar under control.
In a statement, Merck quoted one of its paid consultants, Edward Horton of the Harvard Medical School, as saying: "Patients who are unable to adequately manage their Type 2 diabetes with lifestyle changes, like healthy eating and increased physical exercise, and who require medications now have a new product to help regulate their blood-sugar levels."
Besides Januvia and Galvus, another drug, Byetta, was launched last year by Eli Lilly & Co., of Indianapolis, and Amylin Pharmaceuticals Inc., of San Diego. New York-based Pfizer launched an inhalable insulin, Exubera, earlier this year.
And Merck is seeking FDA approval to market a combined Januvia-metformin pill next year.
The makers of older treatments are still pushing hard. London-based GlaxoSmithKline said last month that its studies showed that its older drug, Avandia, could prevent diabetes in some children. France-based Sanofi-Aventis has launched a campaign to promote insulin, which some physicians
call very effective but sometimes cumbersome.
"Insulin always works. But its reputation is that it makes you look like an addict, or that it's a last resort," said William W. Quick, a New Jersey endocrinologist and onetime drug-safety expert for several drug companies who now runs DiabetesMonitor.com, a patient-information Web site that takes no industry funds, other than ads.
Merck said it would emphasize that Januvia, in an easy, once-a-day pill, is at least as effective as current treatments.
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Novartis said it expected to get FDA approval by year's end for Galvus - also a made-up name, referring to its "galvanizing" effect on pancreatic cells. Novartis has signed Eagles quarterback Donovan McNabb and his father, Sam, a Type 2 diabetic, to promote diabetes care under the Novartis banner.
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Physicians and patients must brace for a full-blown blitz in sales calls and ads.
"The stakes are very high," said Quick, the New Jersey endocrinologist. "With the two drugs likely to get approved within weeks of each other, the noise will be deafening."
