Janssen Announces FDA Approval of Ponvory (ponesimod) for the Treatment of Relapsing Forms of Multiple Sclerosis

On March 19, Janssen, a subsidiary of Johnson & Johnson, announced that the U.S. FDA had approved Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Ponvory demonstrated superior efficacy in reducing the annualized relapse rate compared to established oral therapies, and its safety profile has been confirmed in cumulative clinical studies spanning more than 10 years. The press release noted that Ponvory is the first and only oral disease-modifying therapy approved by the FDA to be studied against an established oral comparator.

Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS) that impairs normal function of the brain, optic nerves, and spinal cord through inflammation and tissue damage. The progression of MS leads to declines in physical functions (e.g., walking) and cognitive functions (e.g., memory). There are three main types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). Relapsing MS (RMS) is characterized by well-defined episodes of relapse and remission, i.e., acute attacks or worsening of symptoms followed by periods of partial or complete recovery during which symptoms partially or fully improve without evident disease progression. However, with increasing frequency of relapses, the condition of most patients gradually worsens. Worldwide, there are approximately 2.3 million people with MS, and about 85% of them are initially diagnosed with RMS.

Ponesimod is a selective S1P1 receptor modulator. This class of drugs reduces the number of circulating lymphocytes by inhibiting S1P1 receptor activity, thereby sequestering lymphocytes within lymph nodes. Consequently, fewer inflammatory cells can enter the central nervous system (CNS) to damage myelin. Myelin is the protective sheath surrounding nerves, which is damaged by immune cell attacks in patients with multiple sclerosis (MS).

The FDA’s approval was based in part on a two-year Phase 3 clinical trial. In patients with relapsing multiple sclerosis (MS), Ponvory significantly reduced the annualized relapse rate by 30.5% compared with the control drug, demonstrating superior efficacy. During the study period, 71% of patients treated with Ponvory remained free of confirmed relapses, compared with 61% in the control group. Ponvory also outperformed the control drug in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and new or enlarging T2 lesions, with reductions of 59% and 56%, respectively. Ponvory also prevented disability worsening in the majority of patients. Nine out of ten patients treated with Ponvory did not experience 3-month confirmed disability worsening, indicating a numerical benefit in delaying disability progression.

“MS is a complex disease, and individual responses to disease-modifying therapies for MS vary,” said Dr. Bruce Bebo, Executive Vice President of Research at the National Multiple Sclerosis Society. “It is crucial that patients with MS have access to effective treatment options. We are pleased that a new therapy has been approved for the treatment of relapsing MS.”

“Given the variability in underlying conditions and emerging symptoms, each patient with multiple sclerosis is affected differently. Continued innovation in this field is critical, and we are committed to meeting the evolving medical needs of patients,” said Dr. Mathai Mammen, Global Head of Janssen Research & Development at Johnson & Johnson. “We are honored to provide Ponvory as a new treatment option for patients with MS, helping them better manage their disease.”

Janssen submitted a Marketing Authorization Application (MAA) for ponesimod to the European Medicines Agency (EMA) in the first quarter of 2020, for the treatment of adult patients with relapsing multiple sclerosis.

References:

[1] Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions. Retrieved 2021-03-19, from https://www.janssen.com/janssen-announces-us-fda-approval-ponvory-ponesimod-oral-treatment-adults-relapsing-multiple