FDA approves new drug to treat protein buildup in the heart
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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A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. 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In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech's pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech's initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; the timing of and BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech's COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and related expenses; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale BioNTech's production capabilities and manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels, and BioNTech's product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. 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View source version on Contacts Pfizer: Media Relations+1 (212) 733-1226PfizerMediaRelations@ Investor Relations+1 (212) 733-4848IR@ BioNTech: Media RelationsJasmina Alatovic+49 (0)6131 9084 1513Media@ Investor RelationsVictoria Meissner, M.D.+1 (617) 528-8293Investors@
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