Galvus, a drug from Novartis AG has been given the green light from the European Medicines Agency. Now open to the European market, Galvus has nevertheless still no access to its American counterpart.
The decision by a committee of experts at the European Medicines Agency came soon after Novartis said it would not be ready to resubmit Galvus to U.S. regulators until mid-2009, due to a request for more safety data.
Galvus is said to work in a similar way to Merck & Co. Inc.'s recently launched Januvia, though the latter's path to market has been delayed by worries over skin toxicity.
Both Galvus and Januvia are so-called DPP-4 inhibitors, which are designed to enhance the body's own ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes - the most common form of the disease.
The drugs' manufacturers and many analysts believe DPP-4 drugs could sell like hot cakes because they are not associated with weight gain, a major side effect of some established diabetes drugs.
Galvus is being recommended in the European Union for use in combination with other common oral diabetes medicines -metformin, a thiazolidinedione (TZD) or a sulfonylurea (SU).
Says Novartis's global head of pharma development, James Shannon: "Many type 2 diabetes patients need more than one treatment to bring their blood sugar levels under control, therefore the efficacy and tolerability of Galvus in combination with other medicines is especially significant."
As of now, Novartis expects to resubmit its Galvus diabetes treatment for U.S. approval around the middle of 2009, while starting a new study later this year.
"It (the study) will likely take until at least the end of 2008 to complete. And then we would propose to resubmit the dossier to the FDA sometime in mid-2009", Shannon was quoted.