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By Bhanvi Satija and Sneha S K
(Reuters) -U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the entry of a new type of medicine in a market dominated by Pfizer's blockbuster Vyndaqel.
Alnylam is banking on the success of the drug, chemically called vutrisiran, to reach profitability and invest in future treatments. Its drug will compete in the market for transthyretin amyloid cardiomyopathy (ATTR-CM) treatments, which is expected to cross $11 billion in revenues by 2032, according to Global Market Insights.
The injectable drug, Amvuttra, was approved to treat adult patients with ATTR-CM, in which faulty transthyretin proteins accumulate in the heart, potentially causing the organ to fail.
"It's going to help us get to profitability and help us invest in the next generation of molecules," Pushkal Garg, Alnylam's chief medical officer, told Reuters ahead of the decision.
Alnylam's drug Amvuttra was first approved in 2022 to treat nerve damage related to ATTR-CM. This new approval makes it the first drug, available to patients, that can treat both forms of the disease.
Amvuttra reduces the production of the disease-causing protein at the source, unlike Pfizer's Vyndaqel and BridgeBio's Attruby, which stabilize transthyretin production.
Analysts expect nearly $5 billion in Amvuttra sales by 2029, according to data compiled by LSEG.
Alnylam will have to design its commercial efforts to encourage patients to opt for its injectable drug, given oral options are already available, analysts said prior to the decision.
Pricing of the drug will also play a role in how much of the market share Alnylam can capture. For treating nerve damage, Amvuttra carries a list price of $119,351 per prefilled syringe and is given once every three months. Alnylam said it will maintain the same list price for the drug to treat ATTR-CM.
Attruby carries a list price of $18,759.12 for a 28-day supply, while Vyndaqel has a list price of about $268,000 annually for a once-daily dose of 80 milligrams.
Shares of the drugmaker were halted in extended trading hours ahead of the decision.
(Reporting by Bhanvi Satija in Bengaluru and Sneha S K; Editing by Alan Barona)
