Following a label change, Novartis has won EU approval for its trouble diabetes drug Galvus. It will be used in combination with some of the most frequently prescribed oral anti-diabetes medicines. Novartis expect the drug to bring in $250 million to $400 million per year.
Novartis had hoped Galvus could become a multi-billion dollar seller. However, safety issues arising around liver enzyme levels have twice prompted regulators to pass on approving the DPP-4 inhibitor--allowing Merck to beat it to the market with Januvia. FDA requests for more clinical trials of the drug have left it in limbo. Novartis is still in talks with the FDA about Galvus' future, but it may scrap its approval efforts if trial requirements are too rigorous.
- see this release from Novartis
- check out this MarketWatch article