Bylvay

Treats pruritus. NDA 215498, held by Ipsen. Odevixibat.

As of Nov 14, 2026, NDA 215498 (Bylvay), held by Ipsen, was first approved by FDA on Jul 20, 2021, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2021
Review: Priority
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Limitation of Use: BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. ( 12.5, 14.1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Dec 19, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 13, 2023	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 20, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

4 strengths and forms


Bylvay0.2MG · capsule, pellets;oral	Odevixibat	RxReference drug
Bylvay0.4MG · capsule;oral	Odevixibat	RxReference drug
Bylvay0.6MG · capsule, pellets;oral	Odevixibat	RxReference drug
Bylvay1.2MG · capsule;oral	Odevixibat	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 19, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 20, 2025	Supplement 6Labeling · Standard review	Approved	Label Label
Jun 13, 2023	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 8, 2023	Supplement 4Labeling · Standard review	Approved	Label Letter
Oct 21, 2022	Supplement 2Labeling · Standard review	Approved	Label Letter
Jul 20, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 215498
Drugs@FDA: Overview at FDA
Company: Ipsen

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters