By I. Edwards HealthDay Reporter<\/b>
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MONDAY, March 24, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has approved a new drug for a serious heart condition<\/a> that affects thousands of people.<\/p>\n The drug, called Amvuttra<\/a> (vutrisiran), is made by Alnylam Pharmaceuticals and is used to treat transthyretin amyloid cardiomyopathy (ATTR-CM).<\/p>\n ATTR-CM is a disease in which harmful proteins build up in the heart, making it harder to pump blood, according to the American Heart Association<\/a> (AHA).<\/p>\n In one study, Amvuttra helped lower the risk of death and heart problems by 28% over three years compared to a placebo. The drug is given as a shot every three months.<\/p>\n \u201cWe hope this could become our flagship franchise. We\u2019re going to help thousands more patients,\u201d Alnylam CEO Yvonne Greenstreet<\/a> said in an interview with STAT News<\/em>. \u201cIt\u2019s also a transformational moment for the company.\u201d<\/p>\n But the treatment comes at a steep price. Each dose costs about $119,000, or $476,000 per year. That\u2019s more than double the cost of a similar drug from BridgeBio, and more expensive than Pfizer\u2019s pills for the same condition.<\/p>\n \u201cThere are many, many, many undiagnosed patients and substantial unmet need in this space. This market is very large, underdiagnosed, undertreated,\u201d said Dr. Mani Foroohar<\/a>, an analyst with the health care investment company Leerink.<\/p>\n Still, the high cost may make it harder for patients — especially those on Medicare Advantage plans — to get the drug. Private insurers may prefer cheaper options like pills from Pfizer or BridgeBio.<\/p>\n Amvuttra works differently from those drugs. It uses RNA technology to stop the body from making the bad protein, while the other treatments work to stabilize the protein before it causes harm.<\/p>\n In trials, BridgeBio\u2019s treatment showed a 42% drop in deaths and heart hospital visits over 30 months.<\/p>\n Amvuttra\u2019s study showed a 28% drop over three years. But the trials were different, so it\u2019s hard to compare the results directly.<\/p>\n Amvuttra is already approved to treat a nerve-related form of ATTR. With this new approval, Alnylam hopes the drug will reach many more people.<\/p>\n More information<\/strong><\/p>\n Learn more about vutrisiran<\/a>.<\/p>\n