During the company's fourth-quarter conference call, management disclosed it had received additional requests from the FDA for more information. Unfortunately, investors found out in February that the additional 90 days might still not be enough time. As a result, the FDA's decision date on AndexXa was pushed back from Feb. However, the FDA's review of AndexXa hit another roadblock in December when the regulator announced it was extending its AndexXa review by 90 days because Portola Pharmaceuticals had submitted additional requested data that was determined to be an amendment to AndexXa's application. As a result, management refiled AndexXa for an FDA approval in August 2017, restarting the clock on an FDA decision. It took some time, but Portola Pharmaceuticals felt comfortable enough that it had the answers to the FDA's questions last year. The FDA also wanted more information regarding AndexXa's manufacturing.
According to Portola Pharmaceuticals, the rejection was based on the FDA wanting more insight into how AndexXa works in factor Xa drugs other than Xarelto and Eliquis. Unfortunately, rather than giving AndexXa an OK, the FDA issued a complete response letter, rejecting the drug's application.
In those trials, AndexXa significantly reduced the anticoagulant effects of Xarelto and Eliquis, prompting Portola Pharmaceuticals to file for FDA approval in 2016.
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