(In Nov. 22 story, corrects list price of Pfizer's ( PFE ) drug to

about $268,000 from $225,000 in paragraph 3)

Nov 22 (Reuters) - The U.S. Food and Drug Administration

has approved BridgeBio's drug for a rare and deadly

heart condition, the company said on Friday, making it the first

new treatment in a market dominated by Pfizer's ( PFE )

blockbuster Vyndaqel.

The oral drug, branded as Attruby, was approved to treat

adult patients with transthyretin amyloid cardiomyopathy

(ATTR-CM), in which faulty transthyretin proteins accumulate in

the heart and can cause the organ to fail.

BridgeBio plans to price the therapy at $18,759.12 for a

28-day supply. Pfizer's ( PFE ) Vyndaqel is sold at a list price of

about $268,000 a year for a recommended once-daily dose of 80

milligrams.

ATTR-CM causes difficulty for the heart to pump blood to

other parts of the body and causes it to fail if left untreated.

It affects more than 120,000 U.S. adults, according to

non-profit researcher Institute for Clinical and Economic

Review.

Pfizer's ( PFE ) tafamidis capsules, sold as Vyndaqel and

Vyndamax, were approved in 2019 and brought in sales of $3.32

billion in 2023.

BridgeBio's application for Attruby, also known as

acoramidis, was based on data from a late-stage study on 632

patients, where it significantly improved survival and reduced

the frequency of heart disease-related hospitalization after 30

months of treatment.

But the drug did not show statistically significant results

on a secondary goal measuring the number of deaths due to any

cause across treatment and placebo groups at month 30.

Tafamidis and acoramidis are designed to stabilize the

faulty proteins, unlike a drug by Alnylam Pharmaceuticals ( ALNY ) that

which works by reducing the production of the protein. Alnylam's

vutrisiran is approved for treating nerve damage related to the

disease.

BridgeBio has partnered with Bayer to market the drug in

Europe, where it is currently under regulatory review. The

company also has a partnership with AstraZeneca's ( AZN ) unit,

Alexion, for marketing the drug in Japan.

Pfizer's ( PFE ) lower-dose version of tafamidis, sold under the

brand Vyndamax, has a recommended dosage of 61 milligrams taken

once daily as a single capsule.

BMO Capital analyst Kostas Biliouris expects the uptake of

acoramidis to be limited, given it "goes against a very

established drug" and must be given twice daily compared to

once-a-day dosing for Pfizer's ( PFE ) capsules.

Biliouris expects acoramidis to generate global sales of

$2.5 billion at its peak by 2035. Pfizer's ( PFE ) drug clocked in

global sales of $3.32 billion in 2023.

Acoramidis is probably going to have most of its uptake

among patients who are newly diagnosed, at least initially,

Scotiabank analyst Greg Harrison said, adding that having

mortality benefit on the label would make it more competitive.

"It is better for the patient community to have more

options," Harrison said. "It raises awareness and improves

diagnosis rates."

BridgeBio did not immediately respond to a request for

comment on Attruby's launch date in the United States.