Novartis’ Galvus accepted for FDA review

Galvus has been submitted by Novartis for approval by the US food and drug administration (FDA).

Designed to treat type two diabetes, submission follows results from 4,300 patients and is on track to be submitted for European approval by the end of this year.

A daily oral treatment, in trials the DPP-4 inhibitor Galvus showed no significant side-effects such as hypoglycaemia and oedema.

Dr James Shannon, MD, head of development at the Swiss pharmaceutical firm, said of the submission: “Galvus may represent an exciting new option for the treatment of type two diabetes with the potential of helping patients reach and maintain their treatment goals with good tolerability.”

Diabetes affects 195 million people globally and these numbers are set to rocket further, particularly in the developing world, causing a surge in demand for treatment.

In trials, Galvus is said to give “significant” HbA1c reductions over a year of treatment, with good overall tolerability and without causing patients to gain weight.

The new drug works by stimulating pancreatic alpha and beta cells to reduce sugar production from the liver and increase production of insulin to keep blood sugar under control.

Now accepted for submission, the FDA will run its own series of tests and requirements before giving its approval for Novartis to market Galvus in the US.

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