According to Multiple Sclerosis News Today, the European Commission (EC) recently approved PONVORY (ponesimod) for the treatment of adult patients with relapsing and remitting (R/R) or active secondary progressive (SP) multiple sclerosis (MS). Ultimately, this decision follows a similar U.S. approval in March 2021. Altogether, both approval decisions hinged upon data from the Phase 3 OPTIMUM clinical trial.

PONVORY (ponesimod)

Pharmaceutical company Janssen Pharmaceuticals, Inc. (“Janssen”) developed PONVORY. In a news release announcing the U.S. approval, Janssen describes PONVORY as:

a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator…believed to work by keeping immune cells called lymphocytes out of the blood by trapping them in lymph nodes. The way PONVORY exerts therapeutic effects in MS is unknown, but may help keep the lymphocytes out of the central nervous system, where they could cause damage.

The treatment is orally administered. Each day, patients take 20mg PONVORY to help manage their MS.

Phase 3 OPTIMUM Clinical Trial

Altogether, 1,133 adult patients participated in the Phase 3 OPTIMUM clinical trial. During the trial, researchers evaluated the safety, efficacy, and tolerability of PONVORY as compared to Aubagio (teriflunomide). Patients received either 20mg PONVORY or 14mg Aubagio each day for 2 years. Researchers determined that:

• During treatment, PONVORY reduced new inflammatory brain lesions by 56% and lowered relapses by 30.5%.
• Both therapies induced mild-to-moderate adverse reactions. However, no reactions were severe enough for patients to stop treatment.
• Ultimately, PONVORY was relatively safe and well-tolerated.
• Side effects included the common cold, upper respiratory tract infections, hair loss, headache, and elevated liver enzymes. The upper respiratory tract infections, headache, and cold affected both groups similarly. Patients taking Aubagio had significantly higher hair loss percentages. Alternately, elevated liver enzymes were much more common in patients receiving PONVORY.

Overall, researchers determined that PONVORY offered significant benefits for patients with R/R MS as compared to Aubagio.

Multiple Sclerosis (MS)

There are two main forms of multiple sclerosis (MS), a neurological and central nervous system (CNS) disorder that affects the way the brain and body communicate. In the relapsing and remitting form, patients experience periods of remission as well as intensely symptomatic periods. Alternately, in the progressive form, patients experience symptom progression with no remission. MS is thought to be an autoimmune disorder in which the immune system mistakenly attacks the myelin sheath, or the protective covering of nerve cells. Ultimately, this may permanently damage the nerves. An estimated 2.3 million people across the globe have MS, though many cases are either not diagnosed or misdiagnosed. Females are 2x more likely than males to develop MS. Typically, the condition is diagnosed between ages 20-50, though it can affect those outside of this age range.

Symptoms of MS vary. However, these symptoms may include:

• Loss of balance and coordination
• Muscle weakness and/or numbness
• Fatigue
• Muscle spasms
• Poor focus or slowed thinking
• Vertigo or dizziness
• Constipation
• Loss of bowel or bladder control
• Slurred speech
• Anxiety, depression, and irritability
• Blurred vision and/or eye pain