Ondexxya Receives Conditional EU Approval as Expected (PTLA, Buy, $36.44)
Portola Pharmaceuticals announced last Friday that the European Commission granted conditional Marketing Authorization for Ondexxya (andexanet alfa). In the US, the product is called Andexxa; it was approved in May 2018. In March, 2019 management said that it expected this EU approval in May. As in the US, the approval was conditional and was based on data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) that evaluated the safety and efficacy of Ondexxya in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban or apixaban in healthy subjects, and data from the Phase 3b/4 ANNEXA-4 study that evaluated efficacy and safety data from 352 bleeding patients. Results from all three studies were published in The New England Journal of Medicine – ANNEXA-R and ANNEXA-A in 2015, and ANNEXA-4 in February 2019.
The EC grants conditional authorizations to medicines that fulfill a medical need and show a potential benefit to public health, and for which additional data are required by the EC. As part of the conditional approval, Portola will provide the final study reports for both the ANNEXA-4 trial and the randomized controlled clinical trial requested by the FDA, as well as additional pharmacokinetic data.
While this conditional approval was expected, it was a relief when it was actually granted. I believe that Andexxa/ Ondexxya is one of the most important new drugs in biopharma and has blockbuster potential. With the European conditional approval, the key to the stock will be the sales build in the US this year and in Europe late this year and in 2020. On March 13, 2019 I posted Portola: Detailed Update on Exciting 2019 Outlook (PTLA, Buy, $33.35) which I would refer you to for more detail.
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