Friday, July 9, 2021

EC approves Ponvory for relapsing MS




The European Commission (EC) has cleared Janssen’s Ponvory for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease.

The European approval follows the recent announcement of the US Food and Drug Administration (FDA) approval of Ponvory (ponesimod) for RMS in March 2021.

The EC authorisation is based on data from the Phase III Optimum study, which was designed to evaluate the efficacy and safety of once daily oral Ponvory versus Sanfo’s once-daily MS treatment Aubagio (teriflunomide).

In this study, Ponvory demonstrated superior efficacy, with an annualised relapse rate (ARR) reduction of 30.5% compared with Aubagio.

Janssen’s drug also showed statistically significant superiority on one of the study’s secondary endpoints – combined with unique active lesions (CUALs).

Ponvory was found to significantly reduce the rate of new inflammatory lesion on brain MRI by 56% at week 108 compared with Sanofi’s drug.

The among of treatment-emergent adverse events reported in the Optimum study was also similar between the Ponvory and Aubagio treatment groups, with the majority of side effects being mild to moderate in nature and not causing treatment discontinuation.

“At Janssen, our mission is to reduce the burden, disability and devastation caused by diverse diseases of the central nervous system, including multiple sclerosis, for which there remains significant unmet patient need,” said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson.

“The approval of [Ponvory] by the European Commission is a significant milestone as it showcases our continued commitment in neurology, reflecting our deepened focus and commitment to this space,” he added.



Source link

Stay Connected

1,605FansLike
11,000FollowersFollow
342FollowersFollow
775FollowersFollow

Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...