Swiss pharmaceutical giant Novartis' plans to launch diabetes treatment Galvus may be dealt a blow by the Food and Drug Administration at the end of the month, market sources told CNBC Europe.
The FDA will ask for more clinical data on the 100 mg dose of Galvus, expected to be a blockbuster drug with sales of more than $1 billion, CNBC Europe's Dan Scott reported. Only the 50 mg dose will be allowed to market.
If the FDA does proceed in that fashion "it would basically mean that there's not much sense in launching this drug in 2007, or rather until there is an OK for both applications," Scott said.
If that happens, the entire analysts' community will have to change earnings forecasts for the company, due to a major delay in expected revenues, he added.
Galvus approval was already delayed by regulators' requests for more data in November.
Shares of Novartis, already down recently on analyst speculation of a delay, fell a further 1%.