The National Institute for Health and Care Excellence (NICE) has recommended UCB’s bimekizumab as an option for the treatment of adults with severe plaque psoriasis.

This recommendation is the first to follow NICE’s new expedited low risk fast track appraisal (FTA) process, a pathway developed in response to the COVID-19 pandemic to minimise delaying access to new innovative medicines.

NICE noted from the company network meta-analysis that bimekizumab was more effective than three comparator treatments (brodalumab, risankizumab and ixekizumab) in PASI 90 and 100 response.

The recommendation is also supported by results from four Phase III studies, which demonstrated the superior efficacy and safety of bimekizumab in adults with moderate to severe plaque psoriasis against placebo, ustekinumab, secukinumab and adalimumab.

“Designed and developed here in the UK, bimekizumab has shown significant sustained improvements in psoriasis severity in both head-to-head and placebo controlled clinical trials. We’re proud to have worked so collaboratively with NICE throughout this process to help speed up access to this important treatment,” said Claire Brading, managing director UK & Ireland, UCB.

UCB is expecting a decision on marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next few months, which would make bimekizumab available to patients in England and Wales.

“The urgency of the pandemic led to necessary changes to the way NICE prioritised guidance production throughout 2020. As part of our 2021 review into the health technology evaluation process, we are taking this opportunity to introduce new measures to address the impact of the pandemic, including this pilot programme for a limited fast-tracked process," commented Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis (RMS).

The British medicines regulator has cleared Ponvory for the treatment of adult RMS patients with active disease, as defined by clinical or imaging features.

The authorisation is based on data from the Phase III OPTIMUM trial of 1,133 adult patients with RMS in 28 countries. The trial evaluated the efficacy and safety of once-daily oral Ponvory compared with once-daily Sanofi’s Aubagio (teriflunomide), which is an approved and established first-line oral treatment for RMS.

The Phase III study showed superior efficacy of Janssen’s drug compared with Aubagio on the primary endpoint of annualised relapse rate (ARR). Ponvory also showed superiority on one of the secondary endpoints, combined unique active lesions (CUALs), with relative reduction of new or enlarging inflammatory lesions on brain MRI by 56%.

“Unfortunately, there is no cure for multiple sclerosis and a high unmet medical need remains,” commented Gavin Giovannoni, professor of neurology, Blizzard Institute, Barts and The London School of Medicine and Dentistry.

“Disease modifying treatments for relapsing multiple sclerosis are designed to reduce the number and severity of relapses, as well as slow disease and disability progression. Having a new oral therapy will provide patients with greater choice," he added.