Gastroenterology Endpoints For IBD Drugs Once Again In FDA Spotlight
This article was originally published in The Pink Sheet Daily
FDA is holding another workshop to discuss selection of endpoints in development of drugs to treat pediatric and adult inflammatory bowel diseases; the agency held four gastroenterology workshops last year.
You may also be interested in...
Takeda’s drug is in the same family as Biogen Idec’s Tysabri, but is more selective and theoretically safer; no PML cases have been reported for vedolizumab in trials to date. Roche and Pfizer also have different kinds of selective integrin antagonists in development for IBD.
Panelists at an agency workshop discussed tweaks to the Mayo Clinic Score while patient-reported outcome instruments are being developed in an initiative to create an improved ulcerative colitis endpoint.
Clinicians tell FDA that focusing solely on symptoms as an endpoint for pediatric ulcerative colitis and Crohn’s disease ignores the long-term deleterious effects of inflammation. Panel stresses the need to include growth as an endpoint and to conduct pediatric studies earlier.