2022 Western Medical Research Conference



axial spondyloarthritis and psoriatic arthritis :: Article Creator

Positive CHMP Opinion For UCB's Bimekizumab

Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis

UCB has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted marketing authorisation for bimekizumab in the EU.

It concerns the treatment of adults with active axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). AxSpA is an indication that covers both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) – also known as radiographic axSpA (r-axSpA).

In active PsA, the CHMP recommended approval of bimekizumab alone or in addition to methotrexate, for the treatment of adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Furthermore, in active axSpA, the CHMP recommended approval of bimekizumab for treating adults with active nr-axSpA with objective signs of inflammation.

Throughout all four relevant studies – BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 – safety data was consistent with previous studies, including no new observed safety signals.

Meanwhile, the CHMP positive opinions on bimekizumab in active PsA and active axSpA will now be referred to the European Commission (EC), which will deliver a final decision over the coming months. Marketing authorisation will be valid across all EU member states in addition to Norway, Iceland, Northern Ireland and Liechtenstein.

If approved by the EC, these would become the second and third indications for bimekizumab in the EU, following its initial approval in 2021 for the treatment of moderate to severe plaque psoriasis among adult patient groups.

Emmanuel Caeymaex, executive vice president, immunology solutions at UCB, reflected: "The positive CHMP opinion for two new indications for bimekizumab in Europe is a significant step towards our goal of delivering differentiated treatment options to patients."

He concluded: "If approved, bimekizumab would be the first treatment for psoriatic arthritis and axial spondyloarthritis that inhibits IL-17F in addition to IL-17A. Positive results from the four phase 3 clinical studies in PsA and axSpA showed that treatment with bimekizumab consistently resulted in deep levels of response that were rapid and sustained."


Axial Spondyloarthritis

This page shows the latest axial spondyloarthritis news and features for those working in and with pharma, biotech and healthcare.

AbbVie's Rinvoq approved by EC for Crohn's disease

The therapy is also already approved in the EU for adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, as well as for adults


Novartis Gets Positive CHMP Opinion For Cosentyx In Adults With Hidradenitis Suppurativa

Basel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Cosentyx (secukinumab) in adults with active moderate to severe hidradenitis suppurativa (HS).

"HS is an under-treated inflammatory skin disease, and I regularly see its devastating impact in my practice. We need more options that can address its multiple signs and symptoms, especially boil-like abscesses, pain and scarring, and bring fast, long-lasting results," said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany. "The news gives me hope that we may soon have a new option to offer our patients in Europe."

"HS pain can be excruciating at times, limiting my ability to do everyday tasks such as dressing, bathing, walking, exercise, cooking and cleaning. It's humbling to have to ask others to help tie my shoelaces. Beyond the pain, the drainage, fatigue and other HS symptoms impact my relationships, intimacy, mental health, work and finances. New treatment options are needed to help improve the lives for people with HS," said Dr. Barry McGrath, PhD, Acting CEO, HS Ireland.

HS affects 1 in 100 people worldwide, and in Europe, there are around 200,000 people currently living with moderate to severe stages of the condition. The impact of disease is substantial, even for those on treatment, as there is currently only one approved biologic treatment for HS, and around 50% of patients can lose response. HS causes boil-like abscesses that can burst and become open wounds that can result in irreversible scarring, often in the most intimate parts of the body. Patients describe their HS-related pain as the most debilitating symptom, which worsens as disease severity increases.

The positive CHMP opinion is based on robust results from two trials in the largest Phase III program in HS, SUNSHINE and SUNRISE. The data showed that treatment response rates in patients randomized to Cosentyx continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 52. Additionally, approximately 50% of patients randomized to Cosentyx had a meaningful reduction in HS-related pain at Week 52. Safety findings were consistent with the known safety profile of Cosentyx in its approved dermatologic and rheumatologic diseases and are further supported by data from 8 years of real-world use. The full results were recently published in The Lancet.

"This positive CHMP opinion brings us one step closer to offering the first new HS treatment in nearly a decade," said Marie-France Tschudin, President of Novartis Innovative Medicines International and Chief Commercial Officer. "If approved, Cosentyx will provide a much-needed alternative to support the underserved community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms."

"The recommendation for Cosentyx in HS will be referred to the European Commission, which is expected to deliver a final decision within 2 months. The Phase III results from SUNSHINE and SUNRISE have also been submitted to the US Food and Drug Administration with a decision expected later this year," the company stated.

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).





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