Janssen's Oral Multiple Sclerosis Drug Ponvory (ponesimod) Receives MHRA Approval in the UK

Compiled and translated by丨newborn

Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Johnson & Johnson’s new oral multiple sclerosis (MS) drug Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis (RMS). Specifically: adult patients with RMS with active disease defined by clinical or imaging features.

The approval was based on data from the Phase 3 OPTIMUM trial. The trial was conducted in 1,133 adult patients with RMS across 28 countries, evaluating the efficacy and safety of once-daily oral Ponvory versus once-daily oral Aubagio (teriflunomide). Aubagio is an MS drug from Sanofi and is an approved and widely used first-line oral therapy for RMS.

Notably, OPTIMUM is the first study to conduct a head-to-head comparison of two oral disease-modifying therapies for the treatment of relapsing multiple sclerosis (RMS). Results demonstrated that regarding the primary endpoint of annualized relapse rate (ARR), Ponvory exhibited superior efficacy compared with Aubagio, achieving a statistically significant 30.5% reduction in ARR (ARR: 0.202 vs. 0.290; p=0.0003). Furthermore, Ponvory also demonstrated an advantage in the secondary endpoint of combined unique active lesions (CUAL), significantly reducing new or enlarging inflammatory lesions in the brain by 56% (p<0.0001).

MS is an immune-mediated chronic central nervous system disease characterized by inflammation, demyelination, and axonal/neuronal damage, ultimately leading to severe disability. Currently, there is no cure for MS, and a significant unmet medical need remains in this field. Disease-modifying therapy for relapsing multiple sclerosis (RMS) aims to reduce the number and severity of relapse events, as well as slow the progression of disease and disability.

Ponvory is a novel oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which received marketing approval in the United States in March 2021 and in the European Union in May 2021 for the treatment of adult patients with relapsing multiple sclerosis (RMS). It is the fourth drug approved in the S1P modulator class and the ninth branded oral therapy for the treatment of multiple sclerosis (MS).

The market launch of Ponvory will bring a new oral treatment option for patients with relapsing multiple sclerosis (RMS), helping to address some of the lifelong and life-limiting symptoms of MS.

Source: MHRA nod for Janssen’s relapsing multiple sclerosis drug Ponvory