New Meds and Tech from PES Drugs and Therapeutics committee
Palovarotene (SohonosTM – Ipsen Pharmaceuticals Inc.)
By: Ambika Ashraf, MD and Anna Ryabets-Lienhard, DO
On August 17th, 2023, FDA approved Palovarotene (SohonosTM) for the treatment of fibrodysplasia ossificans progressiva (FOP) in girls ≥ 8 years old and in boys ≥ 10 years old and adults. It is a selective gamma retinoic acid receptor (RARγ) agonist, designed to inhibit chondrogenesis and reduce new abnormal bone formation in FOP . Sohonos is available in 1, 1.5, 2.5, 5, and 10 mg capsules . The suggested daily oral dose is 5 mg or a weight-based equivalent for pediatric patients under 14 years of age, taken after a full meal at a consistent time each day . The dose can be modified/increased for flare-up of symptoms [1, 2]. It has an FDA issued black-box warning regarding teratogenicity and premature epiphyseal closure . Clinicians must ensure pregnancy prevention in child-bearing age patients and closely monitor growth and skeletal maturation in growing pediatric patients (FDA label, [1, 2]).
- Pignolo, R.J., et al., Reduction of New Heterotopic Ossification (HO) in the Open-Label, Phase 3 MOVE Trial of Palovarotene for Fibrodysplasia Ossificans Progressiva (FOP). J Bone Miner Res, 2023. 38(3): p. 381-394.
- FDA label. 2023 label (fda.gov).