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PTLA—FDA approves Andexxa—an antidote to bleeding caused by

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DewDiligence Member Level  Friday, 05/04/18 04:28:58 AM
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PTLA—FDA approves Andexxa—an antidote to bleeding caused by FXa inhibitors Eliquis and Xarelto:

https://globenewswire.com/news-release/2018/05/04/1496534/0/en/U-S-FDA-Approves-Portola-Pharmaceuticals-Andexxa-First-and-Only-Antidote-for-the-Reversal-of-Factor-Xa-Inhibitors.html
Quote:
The post-marketing requirement is a clinical trial that randomizes patients to receive either Andexxa or usual care (the type of care the enrolling institution would provide in the absence of Andexxa). This study is scheduled to be initiated in 2019 and be reported in 2023.

For obvious reasons, it will be hard to enroll such a trial if there are trial sites in countries where Andexxa is approved. This post-marketing requirement strikes me as the FDA’s attempt to save face; it’s highly unlikely, IMO, that this trial will ever be completed.

Although not in the FDA label, Andexxa is also an antidote for PTLA’s own Bevyxxa, which is approved in the US but not the EU.

Today was the PDUFA date. PTLA CC at 8:30am ET.

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