SMC accepts Ponvory for RRMS
Posted in Industry News on 18th Nov 2021
Scottish Medicines Consortium (SMC) Accepts PONVORY® (ponesimod), a Once Daily, Oral Therapy, for Relapsing Forms of Multiple Sclerosis
PONVORY® (ponesimod) accepted for use within NHS Scotland for the treatment of relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features, suitable for or requesting an oral treatment1
High Wycombe, UK, 9 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson has welcomed the Scottish Medicines Consortium (SMC) acceptance of PONVORY® (ponesimod) within NHS Scotland as an option for treating adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features, suitable for or requesting an oral treatment.1 Ponesimod offers an additional treatment choice in the therapeutic class of sphingosine-1-phosphate (S1P1) receptor modulators.
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates nerve cells), damaging or destroying it and causing inflammation.2 This affects how the CNS processes information and communicates with the rest of the body, causing the neurologic signs and symptoms of MS.3 Symptoms vary by person, but common symptoms include fatigue, balance and walking problems, numbness or tingling, dizziness and vertigo, vision problems, bladder and bowel problems and weakness.3-5 More than 15,000 people in Scotland currently live with MS.6
Multiple sclerosis can be unpredictable, and the fluctuating nature of the disease can be particularly difficult to manage. Disease modifying treatment options for relapsing-remitting multiple sclerosis are designed to reduce the number and severity of relapses, as well as slow disease and disability progression, meaning that some of the life-limiting symptoms of multiple sclerosis can be potentially minimised for those living with the condition.The SMC acceptance of ponesimod marks a significant step forward for people living with relapsing-remitting multiple sclerosis, providing them an additional treatment option to help manage their condition.” Dr Javier Carod Artal, Consultant Neurologist, Raigmore Hospital, NHS Highlands.*
The SMC’s advice is based on data from the Phase 3 OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients (aged 18-55 years) with relapsing multiple sclerosis (RMS) in 28 countries. The trial was designed to evaluate the efficacy and safety of once-daily oral ponesimod (20 mg) vs. once-daily teriflunomide (14 mg), an approved and established first-line oral treatment, in adult patients with RMS. Data from the study was published in 2021 in JAMA Neurology.7
“We welcome the decision from the SMC to make ponesimod available to people living with relapsing-remitting multiple sclerosis in Scotland,” said Amanda Cunnington, Director of Health Economics, Market Access, Reimbursement, Government Affairs & Patient Engagement, Janssen-Cilag Limited. “This decision further supports our commitment to ensuring patients living with this condition have access to new treatment options to help address some of the life-long and life-limiting symptoms of MS. We will work closely with the SMC and NHS Scotland to ensure that ponesimod will be available for eligible patients as quickly as possible.”
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not result in treatment discontinuation.7 The most commonly reported adverse events in either the ponesimod 20 mg group versus the teriflunomide 14 mg group were Alanine Aminotransferase (ALT) enzyme elevations (19.5 vs. 9.4 percent), nasopharyngitis (19.3 vs. 16.8 percent), headache (11.5 vs. 12.7 percent), upper respiratory tract infection (10.6 vs. 10.4 percent) and alopecia (3.2 vs. 12.7 percent).7-10 The current/currently known safety profile of ponesimod is consistent with the known safety profile of other S1P1 receptor modulators, although no other head-to-head comparisons have been conducted to date.7
1 Scottish Medicines Consortium Medicines advice for ponesimod (Ponvory®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ponesimod-ponvory-abb-smc2384/. Accessed November 2021.
2 National Multiple Sclerosis Society. Definition of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Last accessed: November 2021.
3 National Multiple Sclerosis Society. Symptoms and Diagnosis. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis. Last accessed: November 2021.
4 Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9(1):5-48.
5 National Multiple Sclerosis Society. Cognitive Changes. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Cognitive-Changes. Last accessed: November 2021.
6 Prevalence and incidence of multiple sclerosis. MS Trust. Available at: https://mstrust.org.uk/a-z/prevalence-and-incidence-multiple-sclerosis. Last accessed: November 2021.
7 Kappos L, Fox RJ, Burcklen M, et al. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021;78(5):558–567.
8 PONVORY® (ponesimod). Summary of Product Characteristics – Initiation Pack. Great Britain. July 2021.
9 PONVORY® (ponesimod). Summary of Product Characteristics – Maintenance Pack. Great Britain. July 2021.
10 PONVORY® (ponesimod). Summary of Product Characteristics. EU. May 2021.
11 D’Ambrosio D, Feedman MS, Prinz J. Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases. Ther Adv Chron Dis. 2016;7:18-33.
12 Multiple Sclerosis Association of America. The immune system and multiple sclerosis. Available at: https://mymsaa.org/ms-information/overview/immune-system/. Last accessed: November 2021.
*Dr Javier Carod Artal has received a fee for service from Janssen. He has not been compensated for any media work.
About PONVORY® (ponesimod)
Ponesimod is an oral, highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.11 In patients with multiple sclerosis (MS), inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.12
One of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd, is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.