FDA Approves Sohonos (palovarotene) for the Treatment of Fibrodysplasia Ossificans Progressiva
Ipsen has announced approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification (HO) in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).
FOP impacts the lives of an estimated 400 people in the U.S. and 900 people globally. As the disease continuously progresses with flare-up episodes causing rapid bone growth, HO severely restricts mobility and function. Most people living with FOP inevitably lose the ability to eat and drink on their own, cannot provide self-care or use the restroom themselves, and are unable to maintain employment. By the age of 30 years old, the majority of people with FOP require a wheelchair and full-time caregiver assistance. The management of FOP has previously been limited to palliative care and ultimately, FOP shortens the median life expectancy to 56 years. Untimely death is often caused by bone formation around the ribcage leading to breathing problems and cardiorespiratory failure, or falls resulting in fractures or head injuries because joint ankylosis prevents bracing from a fall.
Sohonos is an oral medicine with particular selectivity for the gamma subtype of retinoic-acid receptors, which are an important regulator of skeletal development and ectopic bone in the retinoid signaling pathway. The medicine is designed to mediate the interactions between the receptors, growth factors and proteins within the retinoid signaling pathways to reduce new abnormal bone formation in FOP. The recommended dosing for Sohonos includes a chronic daily dosage of 5mg (or weight-based equivalent for pediatric patients under 14 years of age), which can be modified/increased for flare-up symptoms.
Sohonos may be prescribed immediately in the U.S. for eligible patients. To ensure access to Sohonos for eligible individuals in the U.S., Ipsen Cares patient support program is available as a resource to people living with FOP and their caregivers to provide educational support and address coverage, access and reimbursement questions (1-866-435-5677).
