Shire files sNDA at FDA for Vyvanse to manage Binge Eating Disorder
Shire plc has announced that the FDA has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with Binge Eating Disorder (BED). The FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
BED is a distinct eating disorder now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). BED is characterized by recurring episodes of eating significantly larger amounts of food in a discrete period of time (eg, any two-hour period) than most people would eat in a similar period of time under similar circumstances.These episodes are associated with feelings of distress and lack of control (eg, the sense one cannot stop eating or control what or how much one is eating).
Related news and insights
Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH])
Merck KGaA, a leading science and technology company, announced that its two Phase III EVOLUTION clinical trials (evolution RMS 1 and evolution RMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (Aubagio) (0.11 vs. 0.11 in evolution RMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolution RMS 2, p=NS in both trials)