Bylvay

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Recruitment Underway for Trial on Long-Term Safety of Odevixibat in ALGS

A new open-label phase 3 clinical trial evaluating the long-term safety and efficacy of odevixibat (A4250) in patients with Alagille syndrome (ALGS) is currently recruiting participants by invitation in the US, France, Poland, and the UK. The trial called ASSERT-EXT is enrolling an estimated 63 adults and children with the disease who completed the 24-week…

Phase 3 Trial Testing Odevixibat for Alagille Syndrome Is Underway

Albireo Pharma is continuing to enroll participants for its phase 3 clinical trial called ASSERT to test the safety and efficacy of their nonsystemic ileal bile acid transport inhibitor odevixibat (Bylvay™) in patients with Alagille syndrome. The trial remains on track for topline results by the end of 2022. “Bylvay launch uptake has been faster…

clinical trial data

Potential ALGS Treatment Approved in the UK for Progressive Familial Intrahepatic Cholestasis

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted odevixibat (Bylvay®) marketing authorization to treat progressive familial intrahepatic cholestasis (PFIC), according to a press release from Albireo, the makers of the treatment. This means the treatment is now approved across the US, EU, and UK for these patients. “The approval of Bylvay in the…

Clinical trial

Phase 3 Trial of Odevixibat Recruiting Patients With Alagille Syndrome

A phase 3 clinical trial is currently recruiting participants with Alagille syndrome to test the safety and efficacy of odevixibat (Bylvay™). Bylvay, manufactured by Albireo, is already approved by the US Food and Drug Administration (FDA) to treat pruritus in progressive familial intrahepatic cholestasis (PFIC).  This clinical trial, called ASSERT, is evaluating the treatment in…

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Potential ALGS Treatment Approved for Another Rare Liver Disease

An experimental treatment for Alagille syndrome (ALGS) has been approved by the US Food and Drug Administration (FDA) for another rare liver disease, called progressive familial intrahepatic cholestasis (PFIC). The approval marks the first approved treatment for PFIC and could help pave the way for a future ALGS indication. The drug, odevixibat (Bylvay™), is a…

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