The intravenous medication, andexanet alfa, was given breakthrough therapy status by the FDA in 2013. This status can help accelerate the development of new drugs for life-threatening conditions that do not currently have other treatments.
Last week, Portola announced that the Phase III ANNEXA-R study met its primary endpoint of “immediately and significantly” reversing Xarelto in 41 healthy volunteers aged 50-75 years old. In October, the medication was also shown to be effective at reversing Eliquis. More data is expected in mid-2015.
Currently, millions of people are prescribed Xarelto for short-term use or chronic conditions. According to Portola, 1-4% of patients treated with Xarelto experience major bleeding and an additional 1% may require emergency surgery. In these situations, a doctor must quickly de-activate any blood-thinning medication a patient is taking.
In the past, when most patients were using the blood-thinner warfarin, the reversal agent was a simple dose of Vitamin K.
Xarelto is a new type of blood-thinning medication that works by inhibiting the blood clotting enzyme factor Xa. It has no antidote that can reverse its blood-thinning effects. Not even dialysis can remove Xarelto from a patient’s bloodstream because Xarelto binds too tightly with proteins in blood plasma.
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