On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved the expansion of the indication for avatrombopag (Doptelet) to include the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura (ITP) who have not responded adequately to prior treatment.
Avatrombopag (Doptelet) was previously approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled for surgery. Earlier, Dova Pharmaceuticals also announced that the European Commission had granted marketing authorization for avatrombopag (Doptelet) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled for invasive surgery.
“Dova Pharmaceuticals is pleased to offer avatrambopag (Doptelet) to patients and physicians in the United States for the treatment of adult patients with chronic ITP who have not responded well to prior treatment,” said Dr. David Zaccardelli, President and CEO of Dova Pharmaceuticals. “In addition to providing a new treatment option for ITP patients, we expect avatrambopag (Doptelet) to address an important unmet medical need in the market. We sincerely thank the patients and dedicated researchers who participated in our clinical trial program, and also thank the FDA for their cooperation during the review of this application.”
Clinical Studies of Avatrambopag (Doptelet)
Avatrambopag (Doptelet) is an oral thrombopoietin receptor agonist (TPO-RA) that must be taken with food. In the pivotal Phase 3 clinical trial, most patients achieved a platelet count of at least 50,000/µL on day 8 of treatment with avatrambopag (Doptelet); and over a 6-month treatment period, it was superior to placebo in maintaining platelet counts within the target range. Additional efficacy data supporting this supplemental New Drug Application for ITP come from two Phase 2 clinical trials of ITP and two Phase 3 clinical trials of thrombocytopenia in patients with chronic liver disease.
Safety data from 128 ITP patients and over 1,000 participants treated in 24 studies covering multiple indications within the avatrombopag (Doptelet) clinical development program demonstrate the safety and tolerability of avatrombopag (Doptelet).
Indications for Avatrombopag (Doptelet)
Avatrombopag (Doptelet) is indicated for the treatment of thrombocytopenia in the following adult patients:
Patients with chronic liver disease scheduled for surgery;
Patients with chronic immune thrombocytopenia who have had an inadequate response to prior treatment.
