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J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

Johnson & Johnson's (J&J) multiple sclerosis (MS) therapy Ponvory has moved closer to approval in the EU, after receiving a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) today.

J&J's pharma division Janssen announced today that the CHMP recommends approval of the marketing authorisation for Ponvory (ponesimod), for the treatment of adult patients with relapsing MS (RMS), with active disease defined by clinical or imaging features.

Ponvory inhibits S1P1 receptor activity, which is believed to reduce the number of circulating lymphocytes.

In people with MS, inflammatory immune cells such as lymphocytes can cross the blood brain barrier into the brain, damaging the protective sheath that insulates nerve cells – known as myelin.

When myelin is damaged, nerve conduction can slow down or stop completely, leading to the neurologic signs and symptoms associated with MS.

The EU marketing authorisation application for the S1P1 modulator is based on data from the phase 3 OPTIMUM trial, designed to evaluate the efficacy of once daily oral Ponvory versus Sanofi’s Aubagio (teriflunomide) in adult patients with RMS.

Ponvory demonstrated superior efficacy on the primary endpoint – annualised relapse rate (ARR) – with a rate reduction of 30.5% compared to Aubagio.

Janssen's drug also showed statistically signifiant superiority on combined unique active lesions (CUAL), a secondary endpoint, with a reduction in the number of new inflammatory lesions on brain MRIs of 56% compared to Aubagio.

“Relapsing forms of multiple sclerosis have varied and often unpredictable symptoms, posing a unique human, societal and economic burden,” said Catherine Taylor, vice president, medical affairs therapeutic area strategy, Europe, Middle East and Africa, J&J Middle East.

“Despite continuous innovations in the treatment landscape, unmet needs remain. If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS,” she added.

Last week, the US Food and Drug Administration (FDA) approved Ponvory for the treatment of RMS.

J&J initially acquired the S1P1 receptor modulator as part its $30bn takeover of Actelion in 2017.

Article by
Lucy Parsons

26th March 2021

From: Regulatory



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