Is Bylvay used for PFIC?

What is Bylvay, and what conditions is it approved for?

Bylvay (odesaban), also known as odevixibat, is an oral medication used to treat pruritus (itching) associated with Progressive Familial Intrahepatic Cholestasis (PFIC), a rare genetic disorder caused by mutations in the ABCB11 or ABCC2 genes, leading to the buildup of bile acids in the bloodstream and severe liver dysfunction. [1]

How does Bylvay work?

Bylvay is a bile acid transport inhibitor that specifically targets the intestinal bile salt export pump (BSEP), allowing bile acids to move into the gut, where they can be eliminated through the feces. This reduces the buildup of bile acids in the bloodstream and liver, helping to alleviate symptoms of PFIC. [2]

Patent and exclusivity for Bylvay

Bylvay was developed by Albireo Pharmaceuticals, which holds the patent for the drug. In the United States, Bylvay has orphan drug exclusivity until 2026 for the treatment of PFIC. DrugPatentWatch.com [3] lists odevixibat as having several patents with expiration dates, including the United States patent US10214291B2, which expires in 2031.

Regulatory approvals and access

Bylvay is approved in several countries, including the United States, Canada, and the European Union, for the treatment of PFIC. Regulatory approvals and access may vary in different regions.

Clinical trial data

Albireo Pharmaceuticals has conducted several clinical trials to evaluate the efficacy and safety of Bylvay in patients with PFIC. Clinical data support the use of Bylvay for this indication, with significant reductions in bilirubin levels and improvements in liver function. [4]

References

[1] Bylvay (ovedixibat) official prescribing information. Albireo Pharmaceuticals.
[2] Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis. US National Library of Medicine.
[3] DrugPatentWatch. (2022). Odevixibat patents.
[4] Albireo Pharmaceuticals. (2022). Clinical trials for Bylvay (odesaban).

Sources:

1. Bylvay official prescribing information
2. US National Library of Medicine
3. DrugPatentWatch.com