FDA approves new drug to treat protein buildup in the heart
The U.S. Food and Drug Administration has approved a new drug for a serious heart condition that affects thousands of people.
The drug, called Amvuttra (vutrisiran), is made by Alnylam Pharmaceuticals Inc. and is used to treat transthyretin amyloid cardiomyopathy.
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.
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.
"We hope this could become our flagship franchise. We're going to help thousands more patients," Alnylam CEO Yvonne Greenstreet said in an interview with STAT News. "It's also a transformational moment for the company."
But the treatment comes at a steep price. Each dose costs about $119,000, or $476,000 per year. That's more than double the cost of a similar drug from BridgeBio, and more expensive than Pfizer's pills for the same condition.
"There are many, many, many undiagnosed patients and substantial unmet need in this space. This market is very large, underdiagnosed, undertreated," said Dr. Mani Foroohar, an analyst with the health care investment company Leerink.
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.
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.
In trials, BridgeBio's treatment showed a 42% drop in deaths and heart hospital visits over 30 months.
Amvuttra's study showed a 28% drop over three years. But the trials were different, so it's hard to compare the results directly.
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.
More information
Learn more about vutrisiran.
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