01:24 PM EDT, 04/26/2024 (MT Newswires) -- Pfizer ( PFE ) said Friday the US Food and Drug Administration has approved Beqvez to treat hemophilia B, a rare genetic bleeding disorder, in adult patients.

Hemophilia B prevents normal blood clotting due to a deficiency in factor IX, or FIX, that causes patients to bleed more frequently and longer than others, the drugmaker said. The World Federation of Hemophilia estimates that more than 38,000 people have hemophilia B globally, according to Pfizer ( PFE ).

The one-time Beqvez treatment helps enable patients to produce FIX themselves instead of the current standard of care, which needs regular intravenous FIX infusions that are often administered several times per week or multiple times every month, according to the company.

Beqvez's one-time administration offers the potential to provide both long-term bleed protection and value to the healthcare system, Pfizer ( PFE ) Chief US Commercial Officer Aamir Malik said.

A phase 3 study showed that Beqvez helped eliminate bleeds in 60% of patients, compared with 29% in the prophylaxis arm. A median annualized bleeding rate of zero was observed during the study's efficacy evaluation period, compared with the prophylaxis arm, which showed a 1.3 rate, the company said.

Pfizer ( PFE ) said it is starting a warranty program based on durability of patient response to treatment. "The goal of the warranty is to provide greater certainty to payers, maximize access for eligible patients who receive Beqvez, and offer financial protection by insuring against the risk of efficacy failure," the company said.

Beqvez recently secured regulatory approval in Canada, while the European Medicines Agency is currently reviewing the treatment, the company said.

Pfizer ( PFE ) is scheduled to report its first-quarter financial results Wednesday. Analysts polled by Capital IQ expect normalized earnings of $0.51 a share on revenue of $13.92 billion.

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