Anyone looking for a case that the FDA is lightening its standards for new products should take a hard look at the agency’s approval for Portola’s betrixaban today.
Last year the company reported that its anticoagulant has just barely failed a key endpoint in examining the drug’s efficacy (p=0.054) among a key cohort of patients with elevated D-dimer levels. The company went on, though, to do an exploratory analysis of the results, claiming a win in reducing the risk of venous thromboembolism — or simply, blood clots — for their drug compared to enoxaparin.
Regulators agreed, approving the therapy for acutely ill patients. And the biotech’s shares took off Friday afternoon after the news hit, rising 46%.
In its release today the FDA zeroed in on the relative number of incidents related to deep vein thrombosis, pulmonary embolism or VTE-mediated deaths in the betrixaban arm compared to enoxaparin: 4.4% compared to 6%.
The company $PTLA put out a short statement on the news:
Prior to today’s approval, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, was approved for in-hospital and extended-duration VTE prophylaxis in acute medically ill patients who are hospitalized.
Portola has had a mixed record at the FDA. Last summer the biotech reported that its anti-anticoagulant andexanet alpha was rejected by the FDA after regulators raised CMC issues.
The drug will be marketed as Bevyxxa.
New FDA Commissioner Scott Gottlieb is committed to maintaining the gold standard on drug R&D, but the emphasis at the agency is on approving new therapies. Portola may have hit regulators at just the right time with that p=0.054 value.
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