Novartis has moved a step closer to bringing its new diabetes drug Galvus to market in the European Union, saying this morning that it had filed for approval of the drug with the European Medicines Agency.
Galvus (vildagliptin) has been submitted for approval as a once-daily, oral therapy for people with type 2 diabetes, for use both as a monotherapy and in combination with other antidiabetic agents.
The drug is a member of the new class of dipeptidyl peptidase-4 inhibitors, which work by enhancing the body’s own ability to reduce blood sugar levels and are thought to offer advantages over other oral drugs for diabetes because of their side effect profile.
In particular the DPP-4 inhibitors are not associated with the weight gain often seen on treatment with other drugs, such as sulfonylureas, which can be a major problem for diabetics.
Novartis filed for Galvus in the USA in March, about a month behind rival Merck & Co which is developing another compound in the same class called Januvia (sitagliptin phosphate). This was just approved in its first market, Mexico, but has not yet been submitted in Europe, giving Novartis a lead in that region.
The market for these drugs could be in the region of $3 billion in the USA alone, according to Morgan Stanley, assuming they win a half share of the market for sulfonylureas.
Commenting on the filing, Prof Emanuele Bosi, director of the diabetes and endocrinology unit at San Raffaele University Hospital in Milan, Italy, said: "Vildagliptin is a new drug with a novel mechanism of action, potentially able to counteract the spontaneous and progressive worsening of the disease."
GlaxoSmithKline and Bristol-Myers Squibb also have compounds in this class in Phase III clinical development, called Redona (denagliptin) and saxagliptin respectively. Eli Lilly recently dropped out of an alliance for another candidate, Taisho's TS-021, in early-stage testing.