Novartis Drug Gets EU Approval
By KATHARINA BART
October 1, 2007; Page B6
In some positive news for Novartis AG, the European Union has granted marketing approval for its Galvus drug for treating Type 2 diabetes. But Novartis still faces a long delay in the more important U.S. market, where the Food and Drug Administration has asked for more clinical data on the drug.
The FDA has requested additional clinical trials of once-daily Galvus, an oral treatment. Novartis, based in Basel, Switzerland, said talks with the FDA are continuing.
Novartis has high hopes for the drug, which it has said has the potential to eventually generate revenue of $1 billion or more, making Galvus a critical development drug, alongside Tekturna, a recently approved pill to control high blood pressure.
The U.S. delay has given Merck & Co.'s Januvia a lead over Galvus. The two similar drugs were originally expected to hit the market at roughly the same time. Novartis doesn't plan to resubmit Galvus to the FDA before 2009, a spokesman said.
The drugs are members of a new class of diabetes medicines called DPP-4 inhibitors, which target a dysfunction in the pancreatic islets that causes high blood-sugar levels in people with Type 2 diabetes.
In most developed nations, diabetes is the fourth-leading cause of death, according to the International Diabetes Federation.
Controlling blood-sugar levels is difficult, even among patients receiving treatment, and more than half of patients with Type 2 diabetes who are on medication aren't reaching their blood-sugar goals. When left untreated or not kept under control, Type 2 diabetes can lead to heart and kidney disease, blindness, and vascular or neurological problems.
Type 2 diabetes most often occurs in people who are older than 45 and overweight, although there has been an increase in younger patients in recent years. Many people with Type 2 diabetes can control their blood-sugar levels through diet and exercise and by taking medications. In more severe cases of Type 2 diabetes, patients also take insulin.
--Anita Greil contributed to this article.
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