Albireo Report Enrollment Completion in P-III (ASSERT) Study of Bylvay (odevixibat) for the Treatment of Alagille Syndrome
- The company reported the completion of patient enrollment in the P-III (ASSERT) study to evaluate the safety & efficacy of Bylvay (120µg/kg/day) vs PBO in 52 patients with ALGS at 35 sites across the EU, North America, Middle East & Asia Pacific. The results are expected to be available at the end of 2022
- The primary efficacy of EPs is a change from baseline in scratching to 6mos. as measured by the Albireo ObsRO & secondary efficacy EPs is a change in serum bile acid levels from baseline to the avg. of 20 & 24wk.
- The company has launched Expanded Access Program (EAP) in the US & EU & provides access to patients treated with Bylvay for ALGS before the product’s approval & reimbursement
Ref: Albireo | Image: Albireo
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