Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 22, 2021

US FDA approves Janssen’s PONVORY for relapsing multiple sclerosis 

The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s (JNJ) PONVORY (ponesimod) for treating adults with relapsing forms of multiple sclerosis (MS).

The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s (JNJ) PONVORY (ponesimod) for treating adults with relapsing forms of multiple sclerosis (MS).

PONVORY is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator.

The approval will also include treatment for the clinically isolated syndrome (CIS), relapsing-remitting and active secondary progressive disease (SPMS).

The latest development is partly based on a two-year, head-to-head Phase III trial in which PONVORY 20mg showed superior efficacy in significantly lowering annual relapses by 30.5% compared to teriflunomide (Aubagio) 14mg in patients with relapsing MS.

In addition, nine in ten PONVORY-treated subjects did not exhibit deterioration of the three-month disability and the treatment demonstrated a numerical benefit in delaying disability progression.

JNJ Janssen research and development (R&D) global head Mathai Mammen said: “Every person with multiple sclerosis is affected differently given the variability in both the underlying disease and emerging symptoms.”

In multiple clinical studies over ten years, PONVORY has shown a proven safety profile and was generally well-tolerated.

Furthermore, if PONVORY treatment is stopped, it leaves the blood within a week, with effects on the immune system waning in one to two weeks in the majority of patients. This could provide further flexibility in managing the treatment.

The European Medicines Agency (EMA) is currently reviewing Janssen’s marketing authorization application (MAA) for ponesimod to treat adults with relapsing MS.

Last week, the World Health Organization (WHO) issued Emergency Use Listing (EUL) for the single-dose Covid-19 vaccine, developed by Janssen for individuals aged 18 years and above.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU