commercial supply of AndexXa will be sourced from our Gen 1 manufacturing process, and due to the limited supply in the first six months, we will focus on a limited number of hospitals to get Andexxa to patients who need it most," said Portola CEO William Lis on a Feb. Agreement from the regulator on that point, among others, opened the door for Andexxa's OK.Īndexxa's commercial launch will be limited at first, with drug product sourced from Portola's first-generation manufacturing process.
Instead, Portola will need to conduct a randomized post-marketing study of Andexxa, set to begin in 2019 and conclude by 2023. Additionally, the label for the drug carries a black box warning for thromembolic risks, ischemic risks, cardiac arrests and sudden death - reflecting the potential adverse side effects of undoing anticoagulation in patients prescribed blood-thinners.Īndexxa's approval is a major relief to investors, whose hopes for the antidote were frustrated first by a three-month delay to the FDA's decision and then by news the regulator might require another clinical trial before approval.
Importantly, though, the FDA OK only applies to use in patients treated with either Bristol-Myers Squibb and Pfizer's Eliquis (apixaban) or Johnson and Johnson and Bayer's Xarelto (rivaroxaban). Wafarin, a cheap generic blood-thinner, has maintained a substantial market share in part due to the availability of Vitamin K as an easy reversal agent. Physicians previously wary of prescribing the new oral anticoagulants due to the lack of a reversal agent will now have a new option to help manage their patients.
In 2016, more than 115,000 such cases were reported in the U.S., according to Portola. With the FDA's decision, Andexxa becomes the first antidote approved to reverse the effects of Factor Xa inhibitors.Īs use of the drugs has risen, more patients have been admitted to hospitals due to Factor Xa inhibitor-related bleeding.
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