Seven years after the FDA's accelerated approval of bleeding reversal agent Andexxa, which was then under the ownership of Portola Pharmaceuticals, the drug's round trip on the U.S. market is coming to an end.
Andexxa, now under AstraZeneca's stewardship, is slated to be pulled from the U.S. market next week, according to a Dec. 18 update from the FDA.
In the FDA communication, the agency notes that it has "received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa." Based on the available data, the agency "considers the risks of the product to outweigh its benefits," it said.
The FDA has shared that position with AstraZeneca, and the company "submitted a request to voluntarily withdraw the BLA for the product for commercial reasons," the agency said.
Andexxa won its original approval as a treatment for patients on the popular blood thinners Eliquis and Xarelto who needed anticoagulation due to life-threatening or uncontrolled bleeding, with a boxed warning describing the risk of thromboembolic events.
While AstraZeneca in 2023 touted the efficacy results of a postmarketing study, that trial recorded a doubling in the rate of thromboses and thrombosis-related deaths at day 30 for patients who received Andexxa versus those who received standard care, according to the FDA.
An FDA advisory panel last year scrutinized the drug's postmarketing data, and the agency later rejected AstraZeneca's application to convert the accelerated approval into a full nod. At that time, AstraZeneca said it planned to keep the drug on the market.
On Friday, an AstraZeneca spokesperson said the company is "confident that Andexxa has a positive benefit risk profile for eligible patients with life-threatening or uncontrolled bleeds."
"In discussions with the FDA, alignment on a feasible path to convert Andexxa from accelerated to traditional approval in the U.S. could not be reached," the spokesperson added.
Portola scored accelerated approval for the drug in 2018 after a pair of prior regulatory setbacks. Rare disease drugmaker Alexion scooped up Portola for $1.4 billion in 2020, and AstraZeneca came in afterward with its massive Alexion buyout.
Last year, AstraZeneca reported full-year Andexxa sales of $219 million.