FDA Expands Use of Avatrombopag for Adults with Chronic Immune Thrombocytopenia

Avatrombopag was previously approved by the agency for treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

Officials with the FDA have approved Dova Pharmaceuticals’ supplemental New Drug Application (sNDA) for expanding the use of avatrombopag (Doptelet). The drug is newly indicated for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Avatrombopag was previously approved by the agency for treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

“Dova is pleased to provide Doptelet to patients and physicians in the United States for the treatment of chronic ITP in adult patients who have had an insufficient response to a previous treatment,” said Dr. David Zaccardelli, president and CEO of Dova, in a prepared statement. “In addition to offering patients with ITP a new treatment option, we expect Doptelet will also address an important unmet medical need in the market. We sincerely thank the patients and dedicated researchers who participated in our clinical program as well as FDA for their collaboration during the review of this application.”

Avatrombopag is an oral, thrombopoietin receptor agonist (TPO-RA) administered with food. In the pivotal Phase 3 study, avatrombopag administration resulted in a platelet count of at least 50,000 per µL at day 8 of therapy in the majority of patients, with efficacy superior to placebo in maintaining platelet counts in the target range during the 6-month treatment period. Additional supportive efficacy data for the ITP sNDA were provided by a pair of Phase 2 ITP clinical trials, as well as a pair of Phase 3 trials for the treatment of thrombocytopenia in patients with CLD.

Safety data for 128 patients with ITP, and more than 1000 subjects treated across 24 studies in the avatrombopag clinical development program across multiple indications, support the safety and tolerability of this drug.

“ITP patients should work with their clinician to choose a therapy that supports their lifestyle and aims to achieve the best possible result to treat their ITP. That’s why having additional treatment options are so important,” said Caroline Kruse, president and CEO of the Platelet Disorder Support Association, in a prepared statement. “We are thrilled to have a new, oral TPO-RA available for adult patients with ITP. Every new treatment provides more choices and new hope to our community.”

The commercial launch of Dova’s avatrombopag product for ITP is expected in July 2019.

Reference

Dova Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application For DOPTELET® (Avatrombopag) For Treatment of Chronic Immune Thrombocytopenia (ITP) [news release]. Durham, NC; June 27, 2019: Dova website. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-announces-fda-approval-supplemental-new. Accessed June 27, 2019.