Everolimus regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 11-1 to recommend approval of an NDA from Novartis for 1.5 mg/day everolimus to prevent acute rejection in de novo renal transplant recipients. The panel also voted 11-1 that Novartis demonstrated the efficacy of everolimus when used in combination with corticosteroids and reduced doses of cyclosporine. On a third question, nine members voted in favor of the product's safety profile with the requirement of a risk evaluation and mitigation strategy (REMS), while three voted against the safety profile. No members voted in favor of its safety without requiring a REMS. ...