Launch odevixibat in the second half of 2021
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 25 Feb 2021
- Due
- 31 Dec 2021
- Delivered
- September 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021.”
What we found
Evidence strength A What the grades mean
Filings show Bylvay received U.S. approval in July 2021 and was announced as available by prescription in Germany in September 2021, within the second half of 2021.
-
A Albireo Pharma, Inc. 10-K filed 2022-03-01
“The FDA granted us a rare pediatric disease priority review voucher, or PRV following the approval of Bylvay for the treatment of pruritis in PFIC in July 2021.” ✓ confirmed on the page
-
A Albireo Pharma, Inc. 10-K filed 2022-03-01
“Bylvay is available by prescription to patients in the U.S.” ✓ confirmed on the page
-
A Albireo Pharma, Inc. 10-Q filed 2022-05-16
“we announced in September 2021 that Bylvay became available by prescription to patients in Germany” ✓ confirmed on the page
Checked 27 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Commercial launch
- Indicative materiality
- Medium rules
- Action
- Launch
- Deliverable
- Odevixibat commercial launch
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- Medium
- Conditional
- Yes: potential regulatory approvals
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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