Name: Atebrioz (zilurgisertib) in Fibrodysplasia ossificans progressiva: Other product development or post-marketing obligations required by the FDA
Published: 2026-09-27T12:28:00-04:00

Product information and disease description Place of product in therapy Approaches to treatment

Other product development or post-marketing obligations required by the FDA

3 evidence topics · 2 sources

Postmarketing requirements and commitments in the approval letter

No evidence found.

Pediatric development in children younger than 12 years

“The PROGRESS development program also continues to advance, with enrollment completed in Cohort 2 of children aged 6 to <12 years, and enrollment underway in Cohort 3 of children aged 2 to <12 years.” (opens the source at this quote in a new tab)

“The safety and effectiveness of ATEBRIOZ have not been established in pediatric patients younger than 12 years of age.” (opens the prescribing information at this quote)

Carcinogenicity studies not conducted before approval

“Long-term carcinogenicity studies have not been conducted with zilurgisertib. In a 6-month repeat-dose toxicity study, rats orally administered zilurgisertib developed dose-dependent basophilic foci of cellular alterations (potential preneoplastic findings) and hepatic iron accumulation in the liver (at exposures comparable to clinical exposure).” (opens the prescribing information at this quote)
“The clinical relevance of these findings, including the potential carcinogenic risk in humans treated with zilurgisertib, is uncertain.” (opens the prescribing information at this quote)

European marketing authorisation application

“In the European Union, a marketing authorization application (MAA) for zilurgisertib is currently under review by the European Medicines Agency (EMA), supported by data from Cohort 1 (patients aged 12 years and older) of the PROGRESS study.” (opens the source at this quote in a new tab)