WASHINGTON -- The FDA approved another thrombopoietin receptor agonist on Monday, for an indication not covered by other drugs intended to raise platelet counts.
The new agent is avatrombopag (Doptelet), approved for use in patients with thrombocytopenia associated with chronic liver disease who are scheduled to undergo medical or dental procedures. "This is the first drug approved by the FDA for this use," the agency .
The first agent with a similar mechanism of action, eltrombopag (Promacta), is indicated for idiopathic thrombocytopenia or chronic hepatitis C resulting in platelet deficiency. However, that drug , particularly when used with interferon and ribavirin in hepatitis C patients.
No such warning is included in . That does not mean the drug is devoid of adverse effects, of course. The agency listed several: fever, abdominal pain, nausea, headache, fatigue, and peripheral edema. Also noted was a risk for thrombosis.
According to the label, dosing is to begin 10-13 days before a scheduled procedure and is to be taken orally with food, once daily for 5 consecutive days. Two doses were approved, with the higher dose for patients with platelet counts below 40 × 109/L; the lower dose is for those with platelet counts of at least 40 × 109/L but less than 50 × 109/L.
Two placebo-controlled trials tested avatrombopag in a total of 435 patients with severe thrombocytopenia and chronic liver disease, who were slated to undergo procedures that would likely require platelet transfusion. Patients receiving the drug showed higher platelet counts and fewer required platelet transfusions compared to the placebo groups.
Avatrombopag had a complicated development history. It was initially developed by a firm called AkaRx, which was absorbed into the Japanese firm Eisai in 2010; then Eisai sold the drug to North-Carolina-based in 2016, which now owns the product.