The United Kingdom’s drug cost-effectiveness watchdog has recommended Alnylam Pharmaceuticals’ heart disease treatment Amvuttra for routine use in England and Wales. The decision, announced Nov. 21, ensures eligible patients will gain access through the National Health Service once final guidance is issued next month, according to the company.
Regulator Cleared Drug in July
The Medicines and Healthcare products Regulatory Agency originally granted Alnylam Amvuttra approval in July for treating transthyretin amyloid cardiomyopathy (ATTR-CM). This condition arises when faulty transthyretin proteins build up in the heart, potentially causing organ failure. The drug is also approved for nerve damage associated with the disease.
Alnylam said the recommendation marks a major step in expanding access to what analysts view as a potentially important therapy. Amvuttra reduces production of the harmful protein at its source, while competing products such as Pfizer’s Vyndaqel and BridgeBio Pharma’s Attruby work by stabilizing transthyretin rather than lowering its production.
Guidance Expected Next Month
The National Institute for Health and Care Excellence will issue its final guidance in December. Once published, NHS clinicians will be able to prescribe Amvuttra to eligible patients without additional approval layers, further solidifying the Alnylam Amvuttra approval impact in the UK health system.
Yvonne Greenstreet, the CEO of Alnylam, said about 1,500 patients in the UK are living with ATTR-CM. She added that the UK remains an important market for the company because of its clinical trial activity and established infrastructure.
The drug, known chemically as vutrisiran, is administered by injection. It has become a key contributor to Alnylam’s revenue, generating $685.3 million in global sales in the quarter ended Sept. 30. That figure more than doubled from the same period a year earlier.
Demand Rising in Global Markets
The U.S. Food and Drug Administration expanded Alnylam Amvuttra approval earlier this year to include ATTR-CM, unlocking access to a multi-billion-dollar market. Greenstreet noted that the United States remains the company’s biggest market, while Japan represents another strong opportunity.
Drugmakers and investors are watching for upcoming data from studies by Novo Nordisk expected in early December. Those results are anticipated to offer clearer insight into how existing therapies for metabolic diseases may influence the treatment landscape for related cardiac conditions.
As Alnylam prepares for final guidance in the UK, the company said it expects broader adoption of Amvuttra in markets where regulatory approvals have recently expanded.
Also Read :- Healthcare 360 Magazine
