Platelet-Boosting Drug Approved to Prevent Surgical Bleeding in Cirrhosis Patients | FDA

The US FDA has approved the thrombopoietin receptor agonist avatrombopag (Doptelet®, AkaRx Inc) for the prevention of bleeding events in patients with chronic liver disease and thrombocytopenia undergoing a planned medical or dental procedure.

Avatrombopag

  • Thrombopoietin receptor agonist, stimulates platelet production
  • Decreases serious bleed risk 2-3 fold in patients w/ severe thrombocytopenia (<50*109/L) and chronic liver disease undergoing invasive procedures for up to 7 days after procedure
  • Most common adverse events: fever, abdominal pain, fatigue, edema, nausea
  • Current treatment: pre-procedural platelet transfusion 
  • May increase risk of thromboembolism in some patients

Evidence

  • 2 Phase III clinical trials (ADAPT-1, ADAPT-2)
  • 435 patients, 40 or 60 mg PO QD x5, procedure 5-8d after last dose
  • >50% of patients had viral etiologies for liver disease
  • Tx and placebo arms similar rates of adverse events

 

What is thrombocytopenia?

Thrombocytopenia occurs when a patient’s platelet count falls below 150*109/L.  Platelets play an important role in the formation of blood clots, and their depletion increases the risk of uncontrolled bleeding.  Chronic liver disease, most often a consequence of viral hepatitis or alcohol use disorder, is among the most common causes of thrombocytopenia.  As many as 84% of patients with liver cirrhosis may develop thrombocytopenia during the course of the disease.

What is a thrombopoietin receptor agonist?

Thrombopoietin agonists increase the rate of platelet production by activating thrombopoietin receptors in the bone marrow.  This leads to increased differentation of megakaryocytes – platelet precursors – and increases circulating platelet counts.  The most widely used thrombopoietin agonist is eltrombopag, which is FDA-approved for the 2nd-line treatment of of chronic idiopathic thrombocytopenia, severe hepatitis C infection, and in refractory aplastic anemia.

 

Source: Press Announcements > FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure

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