FDA OKs Platelet Booster for Liver Disease Patients

Megan Brooks

Disclosures

May 21, 2018

The US Food and Drug Administration (FDA) has approved avatrombopag (Doptelet, AkaRx Inc) to increase platelet counts in adults with thrombocytopenia and chronic liver disease who are to undergo a planned medical or dental procedure.

Avatrombopag, a second-generation oral thrombopoietin receptor agonist that stimulates platelet production, is the first drug to be approved by the FDA for this use. It was reviewed under the FDA's priority review process.

Patients with moderate to severe thrombocytopenia can develop serious or life-threatening bleeding, especially during invasive procedures. Patients with significant thrombocytopenia typically receive platelet transfusions immediately prior to a procedure to increase the platelet count.

"Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions," Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

Avatrombopag was studied in two phase 3 trials (ADAPT-1 and ADAPT-2) that involved a total of 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion.

The trials investigated the use of avatrombopag at two doses, 40 and 60 mg. The doses were selected on the basis of baseline platelet count and were administered orally over 5 days. Patients underwent their procedure 5 to 8 days after receiving the last dose.

At both doses tested, a higher proportion of patients who received avatrombopag demonstrated an increase in platelet count, as compared to those treated with placebo. The patients who received avatrombopag did not require platelet transfusion or any rescue therapy on the day of the procedure, as well as up to 1 week following the procedure.

Results from these trials were presented at the 2017 meeting of the American Association for the Study of Liver Disease.

In clinical trials, avatrombopag was well tolerated. The safety profile of avatrombopag was similar to that of placebo. The most common side effects were fever, abdominal pain, nausea, headache, fatigue, and edema. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking avatrombopag, the FDA said.

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