Singapore is the first ASEAN country to provide government subsidy for eligible patients receiving vutrisiran for transthyretin amyloidosis
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"From September 2026 – eligible patients receiving vutrisiran will receive government subsidies of up to 75%[1],[2]"
"HELIOS-A and B provide strong clinical evidence supporting improved patient outcomes"
SINGAPORE, Sept. 1, 2026 /PRNewswire/ -- Medison Pharma (Medison), the creator of a first-of-its-kind unified global commercialisation platform for breakthrough therapies, today announced that from September 1st, 2026, vutrisiran has been recommended for inclusion in the Medication Assistance Fund (MAF) for government subsidy for stage 1 or 2 hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN), and transthyretin amyloid cardiomyopathy (ATTR-CM).[1,2] Singapore is the first country in ASEAN to provide government subsidy for eligible patients receiving vutrisiran treatment for transthyretin amyloidosis. The treatment cost will be subsidised by up to 75% for eligible patients undergoing treatment with vutrisiran as a monotherapy.[1,2]
Vutrisiran is a RNAi therapeutic that works by delivering sustained knockdown of disease-causing transthyretin (TTR) at its source. It is administered as a subcutaneous injection once every three months, offering a dosing schedule that may reduce treatment burden.
It was approved by the Health Sciences Authority for the treatments of stage 1 or 2 hATTR-PN (October 2024)[3], and wild-type or hereditary ATTR-CM (October 2025)[4]. Vutrisiran is the first treatment approved in Singapore for both hATTR-PN and ATTR-CM.
"At Medison, we believe that patients' lives should not determine their access to breakthrough therapies. We welcome the inclusion of vutrisiran in the MAF following the Agency for Care Effectiveness' rigorous assessment. This decision represents an important step towards improving affordability and access for eligible patients in Singapore. We remain committed to working with healthcare systems and other stakeholders to help expand patient access to approved medicines." said Ms Jocelynn Seah, Head of Singapore, Hong Kong and Taiwan, Medison Pharma Singapore Pte Ltd.
"The inclusion of vutrisiran in the MAF reflects the clinical evidence supporting its use in approved indications and represents an important step towards broader access for eligible patients. Through our partnership with Medison and its global commercialisation platform, more patients in Singapore who may benefit from vutrisiran could have the opportunity to receive treatment, in consultation with their healthcare professionals." said Norton Oliveira, Senior Vice-President and Head of Partner and Emerging Markets, Alnylam Pharmaceuticals.
ATTR-CM: HELIOS-B phase 3 study, which showed 28% reduction in all-cause mortality and recurrent cardiovascular events through 33-36 months, with preservation of functional capacity and quality of life, with four quarterly doses per year[5]
ATTR-CM is a progressive, debilitating and fatal disease[6] in which a transport protein (transthyretin) becomes misshapen, breaks apart and builds up as toxic deposits (amyloids) in the heart muscle. This stiffens the heart, leading to heart failure. The median survival of ATTR-CM patients is 2.6 to 5.8 years after diagnosis.[7] ATTR-CM may be hereditary or wild-type and predominately affects men.[8]
The subsidy decision was based on positive results from the pivotal HELIOS-B Phase 3 study.
Key findings from the clinical trial include:[5]
- Primary endpoint: achieved a 28% reduction in all-cause mortality and recurrent cardiovascular events through 33-36 months.
- Secondary endpoint: reduced all-cause mortality by 36% through 42 months.
- Disease progression: demonstrated significant improvements in functional capacity (six-minute walk test), health status and quality of life, and heart failure symptoms and severity.
Vutrisiran demonstrated a safety profile similar to placebo. Common adverse reactions included injection site reactions and elevated blood alkaline phosphatase and alanine transaminase.[5]
Detailed results from HELIOS-B Phase 3 study were published in The New England Journal of Medicine.[5]
"ATTR amyloidosis is a progressive and often underdiagnosed disease that can significantly affect both survival and quality of life. Vutrisiran offers the advantage of convenient quarterly dosing together with rapid and sustained suppression of transthyretin, the protein that drives the disease process. Clinical studies have shown that it can help reduce disease burden and preserve patients' functional ability and quality of life", said Dr Tang Hak Chiaw, Consultant Cardiologist, Novena Heart Centre.
"The inclusion of vutrisiran in the Medication Assistance Fund is a significant milestone for patients in Singapore. By improving access to an effective disease-modifying treatment, more eligible patients will have the opportunity to receive timely care, while clinicians gain an additional treatment option to support individualised patient management and ultimately improve patients' outcomes," continued Dr Tang.
hATTR-PN: HELIOS-A phase 3 study, which showed 48% of patients experienced improvement in neuropathy impairment, with four quarterly doses per year[9]
hATTR-PN is a rare, progressive genetic disease. It shares the same root cause as ATTR-CM, but its toxic deposits (amyloids) build up in the peripheral nerves and other organs. This nerve damage leads to severe, life-altering complications, including chronic pain, loss of mobility and vital organ dysfunction. At last review, there were 34 known patients with hATTR-PN[1], however the number is likely more now given increasing recognition and access to diagnostics.
Key 18-month findings from the HELIOS-A Phase 3 study:[9]
- Primary endpoint: at nine months, vutrisiran significantly improved neuropathy impairment as measured by mNIS+7 compared with the external placebo group from the APOLLO study. Patients receiving vutrisiran demonstrated stabilisation or improvement in neuropathy measures, whereas neuropathy worsened in the placebo group.
- Secondary endpoint: vutrisiran slowed disease progression and improved measures of neuropathy impairment, disability, quality of life and gait speed.
The most common adverse reactions were arthralgia (joint pain) and pain in the arms and legs.[9]
Detailed results from HELIOS-A Phase 3 study were published in Amyloid.[9]
For additional information about AMVUTTRA®, please see the full prescribing information.
About AMVUTTRA® (vutrisiran)
AMVUTTRA® (vutrisiran) is an RNAi therapeutic that delivers rapid knockdown of transthyretin (TTR), addressing the underlying cause of transthyretin (ATTR) amyloidosis. Administered quarterly via subcutaneous injection by a healthcare professional, AMVUTTRA is approved and marketed in Singapore for the treatment of hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN) and for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
About ATTR
Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by misfolded transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant and affects approximately 50,000 people worldwide, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant and impacts an estimated 200,000 – 300,000 people worldwide.
About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today's medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.
About Medison
At Medison, we are addressing one of the pharma industry's most pressing challenges: enabling access to breakthrough therapies for patients with severe and rare diseases in international markets where traditional commercialization models fall short.
As the creator and leader of the global partnership category, we have built a first-of-its-kind unified commercialization platform that enables biotechs to effectively plan, optimize and launch their therapies on a global scale.
With a strong leadership team and a proven track record, we are the partner of choice for innovative biotech companies seeking to expand beyond the US, Western Europe and Japan into regions where most of the world's population resides. Our affiliate-like model integrates commercial, medical and operational capabilities across diverse geographies, accelerating access and delivering life-changing treatments to more patients, faster.
Medison is on a mission to ensure that every patient, regardless of where they live, has the opportunity to benefit from breakthrough therapies. For more information, please visit https://www.medisonpharma.com/
About Alnylam
Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. RNAi therapeutics represent a clinically validated approach that has yielded five Alnylam-discovered medicines that have received marketing authorization in markets around the world.
Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is headquartered in Cambridge, MA.
For more information about Alnylam please visit www.alnylam.com.
About Medison's Partnership with Alnylam
Medison has a global partnership with Alnylam to commercialize RNAi therapeutics in various markets, including Asia-Pacific (including Australia) Europe, Israel, and Latin America. This partnership reflects Medison's and Alnylam's belief that every patient, wherever they are in the world, deserves a fair chance to receive disease-modifying, highly innovative therapies.
Healthcare professionals are asked to report any suspected adverse reactions by contacting safety.singapore@medisonpharma.com
References
[1] Agency for Care Effectiveness (ACE), Drug Guidance, Eplontersen and vutrisiran for hereditary transthyretin amyloidosis with polyneuropathy, https://www.ace-hta.gov.sg/healthcare-professionals/ace-technology-guidance/drug-guidance/eplontersen-and-vutrisiran-for-hereditary-transthyretin-amyloidosis-with-polyneuropathy/ (Accessed on 2026-07-06)
[2] Agency for Care Effectiveness (ACE), Drug Guidance, vutrisiran-for-transthyretin-amyloid-cardiomyopathy, https://www.ace-hta.gov.sg/healthcare-professionals/ace-technology-guidance/drug-guidance/vutrisiran-for-transthyretin-amyloid-cardiomyopathy/ (Accessed on 2026-07-06)
[3] https://www.hsa.gov.sg/announcements/new-drug-approvals---october-2024/ (Accessed on 2026-07-30)
[4] Health Sciences Authority (HSA), New drug approvals - October 2025, https://www.hsa.gov.sg/announcements/new-drug-indication-approval---october-2025/ (Accessed on 2026-07-06)
[5] Fontana M., Berk J L, Gillmore, J D, et al. New England Journal of Medicine. 2024;392(1), 33-44
[6] Hawkins PN, et al. Ann Med. 2015;47(8):625-638
[7] Kittleson MM, et al. J Am Coll Cardiol. 2023;81(11):1076-1126
[8] Dispenzieri A, et al. Orphanet J Rare Dis. 2022;17(1):236
[9] Adams D, et al. Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial. Amyloid 2022 https://doi.org/10.1080/13506129.2022.2091985
- 発信企業・団体
- Medison Pharma
- 業種カテゴリ
- 医療・健康・介護
- 発表日時
- 2026-09-01 11:00 (JST) 原文: 2026-09-01 10:00 (+08:00)
- 原文
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