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FDA approves first drug therapy for fatal pediatric liver disease to avoid liver transplantation and surgery

 Last Update: 2021-07-28
 Source: Internet
 Author: User

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Albireo Pharma announced today that the US FDA has approved Bylvay (odevixibat) for marketing

PFIC is a rare childhood disease that causes progressive, life-threatening liver disease

Bylvay's approval is supported by data from two global phase 3 clinical trials, PEDFIC 1 and PEDFIC 2

PEDFIC 2 is a long-term, open-label, phase 3 extension study that once again confirms that Bylvay can continuously reduce serum bile acids in patients treated for up to 48 weeks, and improve pruritus assessment, growth, and other liver function markers

Note: The original text has been deleted

Reference materials:

[1] Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC).

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Courier FDA approves the first drug therapy for fatal pediatric liver disease to avoid liver transplantation and surgery

08-05

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FDA approves first drug therapy for fatal pediatric liver disease to avoid liver transplantation and surgery

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Courier FDA approves the first drug therapy for fatal pediatric liver disease to avoid liver transplantation and surgery