ARTICLE | Clinical News

Afinitor everolimus regulatory update

November 1, 2010 7:00 AM UTC

Novartis disclosed in its 3Q10 earnings that it submitted an MAA to the European Medicines Agency for Afinitor everolimus in July to treat subependymal giant cell astroctyoma (SEGA) associated with tuberous sclerosis (TS). Afinitor has Orphan Drug designation in the EU to treat TS. An sNDA is under Priority Review in the U.S. for the indication with an Oct. 29 PDUFA date. ...