Andexxa

I read today that the FDA in the Us have approved Andexxa the new reversal agent for Apixaban and Rivaroxaban. Sounds like good news for those of us on these NOACs. Here’s hoping NICE follow suit for us in the UK.

[Luludean]

Need to know more.

[Hidden in reply to Luludean]

Sorry, I’m not tech savvy, but this is copied & pasted from the article posted on the American Stop Afib site. It hasn’t come out quite as seen!

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Andexxa will go nationwide with FDA nod on Portola's commercial production of the bleeding antidote

by Eric Palmer | Jan 2, 2019 10:33am

Portola

The FDA has given the go-ahead for large-scale production of Andexxa, the bleeding antidote from South San Francisco-based Portola. (Portola)

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Portola will finally see the commercial release of its universal bleeding reversal agent Andexxa, a milestone not only for the biotech but also for Pfizer and Bristol-Myers Squibb, as well as Bayer and Johnson & Johnson, whose blood thinners rely on it as a bleeding antidote.

The FDA this week approved Portola Phamaceutical’s second-generation Andexxa after being delayed more than two years because of concerns about its large-scale production processes. The agency approved the drug last spring but only allowed Portola to offer clinical supplies while the company tested its commercial production methods. As a result, the company had to limit supplies to about 1,000 healthcare providers.

“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland said in a statement. Garland became Portola CEO in September, replacing Bill Lis who retired after 20 years with the company. "We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”

[PMRPete]

sps.nhs.uk/medicines/andexa...

nice.org.uk/guidance/indeve...

"29 November 2018 - In progress, Topic referred"

[Hidden in reply to PMRPete]

Thanks Pete. You are better at the links than I am