FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

August 01, 2018

Thrombocytopenia in Chronic Liver Disease: Doptelet (avatrombopag)

Indication: Indicated for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.

Mechanism: Second-generation orally administered thrombopoietin receptor agonist (TPO-RA). Stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets.

Dosage:

Taken orally once daily for 5 consecutive days with food.

Initiate dosing 10-13 days prior to the scheduled procedure.

Patients should undergo their procedure 5-8 days after the last dose.

Dose based on preprocedure platelet count:

Platelet count <40 x10⁹/L: 60 mg PO once daily x 5 days
Platelet count 40 to <50 x10⁹/L: 40 mg PO once daily x 5 days

Approval was based on the ADAPT-1 and ADAPT-2 clinical trials (N=435). The trials investigated the use of avatrombopag at 2 doses, 40 and 60 mg. The doses were selected on the basis of baseline platelet count and were administered orally over 5 consecutive days. Patients underwent their procedure 5-8 days after receiving the last dose. At both doses tested, a higher proportion of patients who received avatrombopag demonstrated an increase in platelet count compared with patients who received placebo.

The primary endpoint was the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following the procedure. Patients who received avatrombopag met the primary endpoint of 65.6-68.6%, compared with 22.9-33.3% who received placebo. Patients who received avatrombopag 40 mg met the primary endpoint of 87.9-88.1%, compared with 38.2-33.3% who received placebo.

Reference:

Terrault N, Chen YC, Izumi N, et al. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 May 17. https://www.ncbi.nlm.nih.gov/pubmed/29778606

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.

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