BMS’ next-generation multiple sclerosis treatment on the PBS

Pharma News: Effective 1 March 2021, Bristol-Myers Squibb/Celgene’s next-generation treatment for relapsing-remitting multiple sclerosis (RRMS) in adult patients will be reimbursed on the Pharmaceutical Benefits Scheme (PBS).

ZEPOSIA (ozanimod) is a sphingosine-1-phosphate (S1P) receptor modulator, which binds with a high affinity to subtype receptors S1P1 and S1P5. It is taken as a once-daily oral capsule and first-dose monitoring is not required.

According to Clinical Associate Professor Todd Hardy, Co-Director of the MS Clinic, Brain and Mind Centre, The University of Sydney, there remains a high clinical need for additional treatment options for patients with RRMS.

“RRMS is the most common type of MS, affecting about 85% of newly diagnosed patients. These patients experience periods of symptoms, or ‘attacks’, followed by partial or complete remission.

“In the past, relapsing MS was an untreatable disease, but the treatment landscape has been comprehensively transformed over the last couple of decades by progress in research and therapeutics.

“Managing MS requires an individualised approach as patients can respond differently to various treatments. As clinicians, we welcome the availability of additional therapy options to help reduce the frequency of relapses and slow disability progression in our patients living with RRMS,” said A/Professor Hardy.

The reimbursement of ZEPOSIA was supported by data from the randomised, active-controlled Phase 3 SUNBEAM and RADIANCE clinical trials, which enrolled more than 2,600 patients across 150 sites in more than 20 countries. During these trials, ZEPOSIA 920mcg dose significantly reduced annualised relapse rates (ARR) compared to Interferon beta-1a intramuscular injection (p<0.0001) and was generally well tolerated.

MS Australia CEO, Mr Rohan Greenland, said the announcement is a positive step forward in helping Australians living with RRMS better manage their condition.

“Each week more than 30 Australians are diagnosed with MS. While research is advancing into the cause, prevention and cure, MS remains an incurable disease. Over the last 15 years, people with MS are being diagnosed earlier, and the outcomes for people with MS have improved significantly, with certain disability milestones being reached later. The PBS listing of ZEPOSIA is a valuable addition to the repertoire of affordable treatments for those patients who are living with RRMS in Australia,” said Mr Greenland.

Neil MacGregor, General Manager of Bristol-Myers Squibb Australia and New Zealand, said today’s listing is another milestone for Australian patients living with MS.

“We share this achievement with the MS patient community and are pleased another treatment option is available from today,” added Mr MacGregor.

BMS’ ZEPOSIA PBS listing adds to the existing S1P modulators Gilenya and Mayzent from Novartis for the treatment of MS patients in Australia.

More than 25,600 Australians currently live with MS. It is also the most commonly diagnosed neurological disease in younger adults, with most people diagnosed with MS between the ages of 20 – 40.