PHARMA/BIO-TECH UPDATE: FDA Grants Breakthrough Status for Factor Inhibitor Antidote

The United States Food and Drug Administration (FDA) has granted Portola Pharmecueticals, Adrexanet alfa – a Factor Xa inhibitor – breakthrough therapy designation.  This designation is intended to “expedite the development and review of drugs for serious or life-threatening conditions,” which, according to the FDA, require, “preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.”

Early findings have shown that Andexanet alfa can reverse the anticoagulant effect of Factor Xa inhibitors.

“The FDA’s decision to designate andexanet alfa as a breakthrough therapy reaffirms the urgent need for an antidote to Factor Xa inhibitors, and we believe it demonstrates that andexanet alfa’s properties and data distinguish it from currently used agents or others in development,” said William Lis, the CEO of Portola, in a press release this morning.

Further Reading: Portola Pharmaceuticals

Photo Credit: portola.com