Drug updated on 4/16/2024
| Dosage Form | Capsule (oral; 1 mg, 1.5 mg, 2.5 mg, 5 mg, 10 mg) |
| Drug Class | Retinoids |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva.
Summary
- Palovarotene (Sohonos) is indicated for the reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females, and 10 years and older for males with fibrodysplasia ossificans progressiva.
- The information was derived from a single study which was a Randomized Controlled Trial.
- In comparison to untreated participants from the FOP natural history study, patients treated with Palovarotene showed a significant reduction in new HO volume by up to 60%, indicating its potential effectiveness as an FOP treatment option.
- However, all patients treated with Palovarotene reported at least one adverse event, including serious events such as premature physeal closure/epiphyseal disorder particularly concerning in younger patients under age 14. This raises safety concerns about using this drug, especially among skeletally immature individuals.
- Additionally, decreased vertebral bone mineral density content strength alongside increased risk of vertebral fractures were noted through post hoc computational analyses using WBCT on palovarotene-treated patients, further emphasizing caution due to these potential risks.
- Given these findings, it is crucial to carefully weigh benefits against risks, particularly for younger or skeletally immature individuals who may be more susceptible to serious side effects like PPC or negatively impacting bone health.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sohonos (palovarotene) Prescribing Information. | 2023 | Ipsen Biopharmaceuticals, Cambridge, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Reduction of new Heterotopic Ossification (HO) in the open-label, phase 3 MOVE trial of palovarotene for Fibrodysplasia Ossificans Progressiva (FOP). | 210Subjects F: 46% M: 54% | 2023 | Journal of Bone and Mineral Research |
Sex Distribution:
F:46%
M:54%
210Subjects
Year:
2023
Source:Journal of Bone and Mineral Research