Bylvay (odevixibat)

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What is Bylvay (odevixibat) for?

Bylvay (odevixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated to treat pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).^[1]

Limitation of use: Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants who have non-functional or complete absence of bile salt export pump protein (BSEP-3).^[1]

It is available in oral pellet form containing either 200 μg or 600 μg of odevixibat or in capsule form containing either 400 μg or 1200 μg of odevixibat.^[1]

How does Bylvay (odevixibat) work?

PFIC is a rare disease that usually develops within the first months of life. It causes life-threatening liver damage that progresses over time and can lead to liver failure. In children with PFIC, cells in the liver are not able to drain bile from the liver even though the large bile ducts are open (cholestasis). This leads to the buildup of toxins in the body. PFIC often causes debilitating itching (pruritus) and liver failure if left untreated.^[2]

Odevixibat, the active ingredient in Bylvay, is a selective inhibitor of the ileal bile acid transporter. It decreases the reabsorption of bile acids from the last part of the small intestine thereby causing bile acids to be excreted through the colon. This is suspected to decrease liver disease and potentially slow or eliminate progression of liver disease.^[3]

Where has Bylvay (odevixibat) been approved?

Bylvay (odevixibat) was approved for the treatment of people with PFIC by:

• The European Medicines Agency (EMA), on July 19, 2021.^[4/]
• The Food and Drug Administration (FDA), USA on July 20, 2021.^[4]

It is the first medicine that is approved for the treatment of all subtypes of PFIC.^[4]

Bylvay was granted Orphan Drug designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis by the FDA.^[5]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Bylvay (odevixibat) taken?

The standard dosage is:^[1]

• 40 μg/kg once daily in the morning with a meal.
• If there is no improvement in pruritus after 3 months, the dosage may be increased in steps of 40 μg/kg up to a maximum of 120 μg/kg once daily not to exceed a total daily dose of 6 mg.

It can be taken as a capsule for older children, or as oral pellets it can be sprinkled onto food.^[1]

Patients taking bile acid binding resins should take Bulvay (odevixibat) at least 4 hours before or 4 hours after taking a bile acid binding resin.^[1]

The treating doctor may change the dose of Bylvay (odevixibat), interrupt treatment or stop permanently if certain side effects occur.^[1]

Complete information about Bylvay (odevixibat) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Bylvay (odevixibat)?

Common adverse reactions

The most common side effects ( ≥2% of patients) listed in the prescribing information include:^[1]

• liver test abnormalities
• diarrhea
• abdominal pain
• vomiting
• fat-soluble vitamin deficiency

Serious adverse reactions

There were no serious treatment-related adverse reactions reported in any clinical study with Bylvay (odevixibat).^[1]

Use in a specific population

It is not known if Bylvay (odevixibat) can harm a fetus. Based on animal studies, Bylvay may cause heart malformations when a fetus is exposed during pregnancy.^[1]

It is not known if Bylvay (odevixibat) passes into breast milk. Breastfeeding should be avoided during treatment and for 1 month after the final dose.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Bylvay (odevixibat) [PDF]
Albireo Pharma, Jul 2021

2. Progressive Familial Intrahepatic Cholestasis (PFIC)
Cincinnati Children’s Hospital Medical Center, cited Jul 2021

3. About Bile Acids and IBAT Inhibition
Albireo, cited Jul 2021

4. Albireo Receives European Marketing Authorization of Bylvay™ (odevixibat), the First Drug Treatment for Progressive Familial Intrahepatic Cholestasis (PFIC)
Albireo, Jul 2021

5. Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
Albireo, Jul 2021