WebIn Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. WebOct 11, 2024 · The double-blind, randomized, placebo-controlled trial was designed to evaluate the safety and efficacy of 120 µg /kg/day Bylvay (odevixibat) for 24 weeks in …
Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to …
WebPatients currently accessing Bylvay via the EAP, or clinical trial, will continue to receive treatment. Expanded Access Program for Alagille Syndrome Albireo is studying Bylvay … WebJun 25, 2024 · For general information, Learn About Clinical Studies. Criteria Key Inclusion Criteria: A male or female participant with a clinical diagnosis of PFIC Type 1 or 2 and with a body weight above 5 kg Participant must have clinical genetic confirmation of PFIC-1 or PFIC-2 Participant must have elevated serum bile acid (s-BA) concentration hog roast for 30 people
Bylvay (odevixibat) to Treat Progressive Familial Intrahepatic Cholestasis
WebMar 8, 2024 · Trial 1 is a randomized, double-blind, placebo-controlled, 24-week study of two dose levels of BYLVAY (40 mcg/kg and 120 mcg/kg) administered once daily. Sixty-two patients were randomized (1:1:1) to receive one of the following: BYLVAY 40 mcg/kg/day (n=23), BYLVAY 120 mcg/kg/day (n=19), or Placebo (n=20). WebIn a clinical trial, diarrhea was reported in 2 (10%) placebo-treated patients, 9 (39%) Bylvay-treated 40 mcg/kg/day patients and 4 (21%) Bylvay-treated 120 mcg/kg/day patients. Treatment interruption due to diarrhea, occurred in 2 patients with 3 events during treatment with Bylvay 120 mcg/kg/day. WebMar 29, 2024 · The double-blind, randomized, placebo-controlled trial is designed to evaluate the safety and efficacy of 120 µ g /kg/day Bylvay (odevixibat) for 24 weeks in relieving pruritus in patients with ALGS. Secondary endpoints will measure serum bile acid levels and safety and tolerability. hubbles beach