Despite being a latecomer to the market, Johnson and Johnson’s drug to treat multiple sclerosis has performed well in a recent study compared to a similar oral MS drug.
Ponvory received FDA approval in March 2021 to treat relapsing forms of MS in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The approval was partially based on a phase three clinical trial comparing the efficacy of ponismod (Ponvory) with teriflunomide (Aubagio), another oral MS drug. The study’s results also led the European Commission (EC) to approve the drug for treatment in its 27 member states.
The Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial was a randomized, double-blind trial comparing the two MS drugs. The participants in the trial were aged 18-55, and the study was conducted at 162 centers in 28 different countries over 108 weeks. The trial compared the two drugs head-to-head and evaluated the efficacy, safety, and tolerability of a 20 mg dose of Ponvory compared to a 14 mg dose of Aubagio in adult patients with relapsing MS.
Throughout the study, the main focus was to compare the drugs’ effect on the annualized relapse rate (ARR). The results showed that Ponvory had 30.5% better efficacy than Aubagio in significantly lowering annual relapses. The study also revealed that 71% of patients treated with Ponvory reported no confirmed relapses. This is in comparison to 61% of Aubagio-treated participants. Ponvory was also found to not increase fatigue and other related symptoms compared to Aubagio, which increased symptoms by just over 3.5%.
Another area where Ponvory performed significantly better than Aubagio was in reducing brain lesions visible on an MRI. The study showed that brain lesions were 56% lower in Ponvory-treated patients than in those treated with Aubagio.
One other result of the study was Ponvory’s ability to delay disability progression for MS patients. The drug demonstrated a numerical benefit in delaying disability progression, with 90% of participants treated with Ponvory not exhibiting any deterioration of the three-month disability.
Almost 90% of all the participants in the trial experienced adverse events or negative side effects, with Ponvory causing slightly more to drop out of the trial for this reason. However, more Aubagio-treated patients left the trial due to lack of efficacy than those treated with Ponvory. Overall, the researchers concluded that Ponvory was well tolerated, and safety findings remained consistent with previous studies of the drug and others in its class.
Ponvory is formulated to be taken orally once a day. It works as a modulator for the oral selective sphingosine-1-phosphate receptor 1 (S1P1) by binding to it with high affinity. The drug has also been shown to trap lymphocytes in the lymph nodes, keeping them out of the blood. How Ponvory provides its therapeutic action in cases of MS is not known. However, it has been suggested that it may help in reducing the migration of lymphocytes into the central nervous system (CNS).
According to a recent survey about physician opinions, Ponvory, has received good feedback, despite being a latecomer to the market. It is the fourth drug of its kind to come to market.
According to Virginia Schobel, Neurology franchise head for Spherix, who surveyed the physicians’ opinions, due to the available alternatives, many doctors can wait to see how Ponvory performs over the next six months before deciding if to prescribe it.
Where Ponvory may gain an advantage over its competitors is for patients who are looking to start families. According to Schobel, unlike most other MS drugs, Ponvory clears out of a person’s system within a week. This benefit appears to be driving many doctors’ inclination to prescribe it over its competitors for patients looking to conceive.
While Johnson and Johnson are not specifically marketing the drug to doctors along these lines, Schobel believes they should be. The key to Ponvory’s success, she feels, may be how they differentiate it from its main competitors.
“If Janssen can differentiate and lay out where they’re going to play, present the data and explain why it makes sense, then yes, it will be interesting to watch,” Schobel said.
At the moment, Ponvory has had a relatively slow uptake in the number of neurologists prescribing it. Spherix’s survey data suggests the low prescription rate might be caused by neurologists having difficulty understanding how it differs from other similar medications. It could also be because only a small percentage of neurologists have been contacted by Johnson and Johnson reps during the first few months of sales. According to the data, where doctors are prescribing it, the second most cited reason for doing so is that patients are requesting it.
“It’s interesting the breadth of brands physicians are discussing with patients before starting on Ponvory. It’s not just S1Ps but also includes high efficacy B-cell therapy and at the other end of the spectrum, the fumarate class, which includes low-cost generic options,” Schobel said.
Ponvory has shown a lot of early promise. How well it does may depend on how effectively Johnson and Johnson can convince doctors to prescribe it.
Written by Chaim Ford
- CENTER FOR DRUG EVALUATION AND RESEARCH
- Europe approves Ponvory (ponesimod) for multiple sclerosis
- Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis – Full Text View – ClinicalTrials.gov
- PONVORY (ponesimod) for the Treatment of Multiple Sclerosis, US
- Results: Ponvory for MS Outperformed Aubagio in OPTIMUM Clinical Trial
- J&J’s Ponvory may be late to the multiple sclerosis market, but doctors still see potential: study