March 19, 2021

The U.S. FDA has approved Ponvory™ (ponesimod), manufactured by Janssen, to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease.

Multiple sclerosis is a disease in which the immune system mistakenly attacks the protective coverings of the body’s nerves. This leads to problems in the body’s ability to send signals from the brain. Symptoms can include pain, vision loss, fatigue, impaired motor skills, bladder and bowel issues, numbness, tingling sensations, emotional and cognitive changes, and vertigo. Patients may experience periods of remission in which symptoms fully or partially resolve before the patient relapses (experiences a return or worsening of symptoms).

In a clinical trial, 71% of patients treated with Ponvory had no confirmed relapses versus 61% treated with teriflunomide, a current standard of care. Ponvory also reduced the number of new gadolinium-enhancing (GdE) T1 lesions by 59% and reduced the number of new or enlarging T2 lesions by 56%. GdE T1 and T2 lesions occur in the central nervous system and are identified using magnetic resonance imaging (MRI) to help gauge disease activity and burden in MS patients.

Under the recommended dosing, Ponvory should be titrated from a starting dose of 2mg on Day 1 to a maintenance dose of 20mg starting on Day 15. Ponvory is an oral tablet taken once daily. Patients who have certain preexisting cardiac conditions should be monitored by a healthcare professional for at least four hours after taking the first dose due to a risk of bradycardia (slower than normal heart rate).

Ponvory has launched at a wholesale acquisition cost (WAC) of $8,083.50 per month.

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