The U.K.'s SkyePharma says the FDA has officially rebuffed its NDA for the asthma drug Flutiform, its lead drug prospect, spelling out "substantive" issues that need to be resolved ahead of an approval.
"The FDA stated (in its complete response letter) that it could not approve the NDA in its present form and raised a number of substantive issues to be addressed, which, if undertaken, would involve significant additional clinical work including work to provide the additional data on dosing as previously disclosed," says the company in a release. None of this could be a big surprise at SkyePharma, which revealed back in September that the FDA was demanding more clinical work on the drug.
SkyePharma says it plans to seek a meeting with the FDA "to determine what steps would need to be taken before the application
can be approved. Further information on the impact of the additional work on timing and costs will be announced once clarification has been obtained."
SkyePharma had estimated annual sales of the therapy at $500 million. The company says that its European application remains on track.
- check out SkyePharma's announcement