After Portola (PTLA) presented data at the European Society of Cardiology 2016 meeting on the interim results from its AndexXa (andexanet alfa) trial, the NEJM published an article summarizing those data. This is available to non-subscribers via the above hyperlink. For seriously interested people, the article contains a link to the full Protocol, in the article's Methods section (first paragraph).
I'm not convinced that the data are compelling in making a case for near-universal use of andexanet as hoped for in appropriate bleeding situations. That said, it's going to take some time to go through the article a second or a third time, and review the protocol in more detail. Also, the NEJM linked to the results of BI's data for its reversal agent for its Pradaxa, which competes with the Xa inhibitors which AndexXa inhibits. So I'll try to present my interpretation of the PTLA ASAP, which may take until next week.
It's worth noting that PTLA's press release reporting FDA's Complete Response Letter to its BLA for AndexXa included this detail (bolded emphasis added by me):
In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola's post-marketing commitments that recently were submitted.
Exactly how material these amendments were that apparently contributed to the non-approval of AndexXa by FDA is not clear to me at this point.
More to come on this high-profile biotech product.