Public health company The US Food and Drug Administration revealed on Monday that it has approved Doptelet (avatrombopag) tablets for the treatment of low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

The US FDA granted Doptelet (avatrombopag) tablets' approval to AkaRx Inc under priority review. This is the first drug approved by the US FDA for this use.

According to the company, the patients with thrombocytopenia typically receive platelet transfusions immediately prior to a procedure to increase the platelet count. The platelets (thrombocytes) are colorless cells produced in the bone marrow that help form blood clots in the vascular system and prevent bleeding.

In conjunction, the safety and efficacy of Doptelet was 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 Doptelet administered orally over five days as compared to placebo (no treatment), stated the company.

For both dose levels of Doptelet, 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 seven days following the procedure as compared to those treated with placebo under the trial, concluded the company.