FDA OKs Amvuttra To Treat Heart Conditions

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on March 24, 2025.

By I. Edwards HealthDay Reporter

MONDAY, March 24, 2025 -- The U.S. Food and Drug Administration (FDA) 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 and is used to treat transthyretin amyloid cardiomyopathy (ATTR-CM).

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 (AHA).

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 healthcare investment company Leerink.

Still, the high cost may make it harder for patients -- especially folks 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.

Sources

  • STAT News, March 20, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-03-25 06:00

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords