Long delayed by a wary FDA, Novartis CEO Daniel Vasella (photo) now says that the diabetes drug Galvus may never be refiled for approval in the U.S. 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. Novartis and the FDA have been engaged in talks about what kind of data is needed to get an approval, but Vasella made it clear in a chat with analysts that no new trial will be mounted until the company gets a clear understanding of what the regulators are looking for.
"It's on the cards that we won't refile, but it's also on the cards that we will," he said in a report carried by Dow Jones. "But what is certainly clear, is that refiling without new data makes no sense." Vasella was also left to explain why Novartis fell far short of Wall Street's expectations for the fourth quarter as generic competition cut deep into its net profits.
- read the report in the Wall Street Journal Health Blog