Novartis moves closer to EU diabetes drug launch

Galvus, a new oral treatment for type two diabetes by Novartis, has moved a step closer to widespread availability following positive feedback from EU health authorities.

The drug was made available in September to patients who were also taking the anti-diabetes medicines metformin, thiazolidinedione or a sulphonylurea.

However, Novartis then released evidence which suggests instances of liver enzyme elevations are less frequent in patients taking a dose of 50mg daily or twice-daily, as opposed to a once-daily 100mg dose.

Following that revelation, the drug manufacturer returned to the Committee for Medicinal Products for Human Use suggesting changes to Galvus’ prescribing information. It responded positively to the findings and has recommended its approval.

Novartis reports that the European commission usually follows the committee’s recommendations and that it anticipates a decision within the next three months.

“More than 21,000 patients have participated in the Galvus clinical trial program to date, including approximately 10,000 treated with Galvus. The medicine is currently available in Brazil and Mexico,” the drugs giant reports.

According to Reuters, the diabetes medicine had been expected to create more than $1 billion (?0.5 billion) in sales before it was limited as a result of safety concerns.