FDA Approval of Bylvay (Odevixibat) for the treatment of Progressive Familial Intrahepatic Cholestasis

We are excited to hear that the FDA has approved Bylvay (Odevixibat) for the treatment of Progressive Familial Intrahepatic Cholestasis. This medication has helped many patients with symptoms of pruritus in clinical trials, and has been approved for use in all subtypes. According to their press release, “Bylvay is expected to be packaged and shipped within the coming days. With the immediate Bylvay launch, Albireo is ready with a focus on access and reimbursement, sales promotion, and patient support…Once Bylvay is prescribed, HCPs and families will have the option to use Albireo Assist™, which is a customized patient support program built with input from patient advocates. The program features dedicated, US-based regional Care Coordinators employed by Albireo who will investigate benefits and review financial assistance options to help ensure optimal patient access. They will also proactively assist with facilitating dosing changes, lab work, refill reminders, reauthorization and other activities.”
Congratulations to Albireo Pharmaceuticals! For the full press release, click here https://ir.albireopharma.com/news-releases/news-release-details/albireo-receives-european-marketing-authorization-bylvaytm

Albireo has prepared and FAQ for patients and families regarding the approval of Bylvay in USA. For more information, please click the button below