FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Gastrointestinal Drugs Advisory Committee (GIDAC)
The committee met to discuss a new drug application (NDA) for Motegrity (prucalopride) tablets for oral administration, submitted by Shire Development, LLC (Shire), proposed for the treatment of chronic idiopathic constipation in adults.
The committee voted unanimously (10 of 10 members) that the clinical trial data provide substantial evidence of effectiveness of prucalopride for the treatment of adults with chronic idiopathic constipation (CIC).
The committee met to discuss a supplemental new drug application (sNDA) for Zelnorm (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch (Sloan). Note that the Investigational New Drug (IND) application for Zelnorm was transferred from its initial holder, Novartis, to Sloan on November 24, 2015, and US World Meds, LLC is acting as an authorized agent for Sloan on the sNDA.
A majority of the Committee, 7 of 12 members, voted that “IBS-C females at low CV risk” is the patient population in whom they would expect the benefits to outweigh the risks. Three of 12 members voted that “IBS-C females at low CV risk and who are severely symptomatic” is the patient population in whom they would expect the benefits to outweigh the risks. One committee member voted that “IBS-C females,” with no qualification for CV risk, is the patient population in whom the benefits are expected to outweigh the risks. He elaborated that although the indication should be kept broad, labeling should include information about the both safety signals to guide prescribing. One Committee member voted for “other” because she felt the appropriate population is IBS-C females at low CV risk who are severely symptomatic and who are also at low psychiatric risk.
The Committee discussed a new drug application (NDA for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates grdeater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia. 21 of 24 members, voted that the overall risk-benefit profile of stannsoporfin does not support approval. Three of the 24 members did support approval with a REMS.
The Committee discussed a supplemental new drug application (sNDA) for Xeljanz (tofacitinib) tablets, by Pfizer Inc. (Pfizer), which proposed use for the treatment of adults with moderately to severely active ulcerative colitis with an inadequate response, loss of response or intolerance to conventional therapies [corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP)] or tumor necrosis factor (TNF) blocker therapy.
The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg twice-daily (BID) dosing as extended induction therapy for a total of 16 weeks in patients who have not achieved adequate therapeutic benefit by Week 8.
The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg BID dosing as an option for continuous maintenance treatment for patients with a history of inadequate response, loss of response, or intolerance to TNF blocker therapy (TNF failures).
The Committee split its vote, with 8 members voting against and 7 members voting in favor, on requiring that Pfizer conduct a post-marketing efficacy trial in the population of TNF failures to compare the 10 mg BID continuous dosing regimen to a regimen of 10 mg induction and 5mg BID as maintenance.
The Committee unanimously supported, by a vote of 17-Yes to 0-No, with no abstentions, the safety and efficacy of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, submitted by Intercept Pharmaceuticals, Inc. The Prescription Drug User Fee Act (PDUFA) goal date for the related new drug application is May 29, 2016.
Gastrointestinal Drugs Advisory Committee (GIDAC)
GIDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.