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 blockbuster Vyndaqel.

BridgeBio Pharma Inc. gained US approval for a drug to treat a progressive and deadly form of heart disease, paving the way for the biotech company to go head-to-head with Pfizer Inc. in an increasingly competitive market.

The Food and Drug Administration approved on Friday a new medicine from BridgeBio for patients with a progressive heart disease — the first new treatment for the condition in over five years and the company’s first significant commercial product. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby.

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

Experts view BridgeBio’s acoramidis—which has an FDA action date of Nov. 29—as either similar to or incrementally better than Pfizer's already established tafamidis.

BridgeBio Pharma’s acoramidis shows improved survival data, boosting approval chances. Read why BBIO stock could see gains if FDA greenlights the drug.