BridgeBio (BBIO) Gets Approval for Heart Drug to Compete with Pfizer (PFE)

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 medication, to be sold under the name Attruby, gained Food and Drug Administration clearance to treat patients with a serious heart condition called transthyretin amyloid cardiomyopathy, or ATTR-CM. The list price will be $18,759 for a 28-day supply.

The decision creates a David versus Goliath matchup between BridgeBio, whose market cap is about $4.4 billion, and Pfizer, valued at about $145 billion. Pfizer sells Vyndaqel and Vyndamax, which use the same active ingredient, tafamidis, to treat the condition. Pfizer’s drugs are priced at the equivalent of about $20,600 for a 28-day supply and generated $3.3 billion in sales last year.

More competition is on the horizon. Alnylam Pharmaceuticals Inc. is expected to get approval next year for its drug to treat the same condition. Earlier this month, Intellia Therapeutics published positive results from an early trial of its gene-editing treatment for ATTR-CM. Ionis Pharmaceuticals Inc. is also developing a drug for the disease, which occurs when a misshapen version of a naturally occurring protein gets deposited in heart tissue.

Once thought to be rare, it’s being diagnosed more frequently due to advances in testing, making it an attractive market for drugmakers. More than 300,000 patients globally have the condition.

BridgeBio had won approval previously for two drugs to treat less-prevalent diseases. ATTR-CM will be the company’s biggest market by far, and investors are waiting to see if the relatively small biotech can compete with Pfizer’s larger sales force.

“People are right to be skeptical,” BridgeBio CEO Neil Kumar said in an interview.

To succeed, BridgeBio will need many doctors to prescribe its drug — a twice-daily pill — ahead of Pfizer’s. Kumar predicted that doctors will choose BridgeBio’s drug because it’s more effective. In a clinical trial, the company’s treatment reduced death and hospitalizations in patients by 42% after 30 months, compared with a 25% reduction with Pfizer’s drug.

“This is a devastating disease that’s been picked up quite late in life and can move very quickly if untreated,” Kumar said. “You’d want the drug that’s potent enough to act as quickly as possible.”