Medication Monitor

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May 23, 2018


FDA approves new drug for patients with chronic liver disease

FDA approved avatrombopag tablets to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first FDA-approved drug for this use.  

Safety and efficacy of avatrombopag were studied in two trials (ADAPT-1 and ADAPT-2) involving 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 two dose levels of avatrombopag administered orally over 5 days compared with placebo.

The trial results showed that for both dose levels of avatrombopag, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure, compared with those treated with placebo.

The most common adverse effects reported by clinical trial participants 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.