With the EC approval, Zeposia becomes the only approved S1P receptor modulator available for the treatment of RRMS patients with active disease

image

Entrance to the Bristol-Myers Squibb building at 100 Nassau Park Boulevard in New Jersey. (Credit: Jonathan Schilling.)

Bristol Myers Squibb has received the European Commission (EC) approval for Zeposia (ozanimod) to treat relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

The US-based pharmaceutical firm said that the EC marketing authorisation makes Zeposia the only approved sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease.

Multiple sclerosis (MS) is a disease caused when the immune system attacks the protective myelin sheath, which covers the nerves. The damaged myelin sheath results in disrupted communication between the brain and the remaining body parts.

Relapsing remitting MS (RRMS) is characterised by attacks of worsening neurologic function, called relapses, flare-ups or exacerbations, followed by partial or complete recovery periods (remissions).

Bristol Myers Squibb chief medical officer Samit Hirawat said: “Today’s European Commission approval provides the opportunity for patients with RRMS with active disease to be offered Zeposia as a new first-line treatment option, which is an important advancement based on Phase 3 trial results showing significant improvements in relapses and brain lesions caused by this devastating disease.

“We share this achievement with the courageous multiple sclerosis patient community in Europe and around the globe, and are working closely with all stakeholders to ensure that eligible European patients can start benefitting from Zeposia as quickly as possible.”

The EC approval for Zeposia is based on data from the SUNBEAM and RADIANCE trials

The European regulatory approval is supported by data from the SUNBEAM and RADIANCE Part B clinical trials, which demonstrated that Zeposia delivered positive results compared to AVONEX (interferon beta-1a).

SUNBEAM is a Phase 3 multicentre, randomised, double-blind, double-dummy, active-controlled clinical study evaluating the efficacy, safety and tolerability of two doses of oral Zeposia against weekly intramuscular AVONEX (interferon beta-1a).

The clinical trial enrolled 1,346 people living with relapsing forms of multiple sclerosis (RMS) across 152 sites in 20 countries.

RADIANCE Part B is a Phase 3 multicentre, randomised, double-blind, double-dummy, active-controlled clinical study evaluating the efficacy, safety and tolerability of two doses of oral Zeposia against weekly intramuscular AVONEX, in 1,320 people with RMS, across 150 sites in 21 countries.

In the Phase 3 SUNBEAM and RADIANCE Part B trials, Zeposia has showed manageable safety and tolerability. The most common adverse reactions include upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain and hypertension.

Vita-Salute San Raffaele University institute of experimental neurology director Giancarlo Comi said: “There is no one-size-fits-all approach to treating MS. Patients respond differently to currently available therapies, which is why having options that address the hallmark characteristics of RRMS is so important.

“Given its demonstrated efficacy and safety profile, Zeposia represents an important new treatment option that I am excited to offer my patients.”