FDA approves sBLA for Doptelet to treat thrombocytopenia in adults

Dova Pharmaceuticals, Inc. announced the FDA approved a supplemental New Drug Application (sNDA) that expands the use of Doptelet (avatrombopag) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Doptelet is also FDA-approved for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. Earlier this week, Dova announced the marketing authorization granted by the European Commission for Doptelet for the treatment of severe thrombocytopenia in adult patients with CLD who are scheduled to undergo an invasive procedure.

Doptelet is an oral, thrombopoietin receptor agonist (TPO-RA) administered with food. In the pivotal Phase III study, Doptelet administration resulted in a platelet count of at least 50,000 per µL at day eight 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 two Phase II ITP clinical trials, as well as two Phase III trials for the treatment of thrombocytopenia in patients with CLD. Safety data for 128 patients with ITP, and more than 1,000 subjects treated across 24 studies in the Doptelet clinical development program across multiple indications, support the safety and tolerability of Doptelet.

Dova is committed to enabling patient access to Doptelet . Dopetelet will be priced similarly to other TPO-RAs used to treat ITP, and Dova will continue to offer Patient Assistance and Co-Pay programs. The commercial launch of Doptelet for ITP is anticipated to occur in mid-July 2019.

Dova also entered into an expanded partnership in the United States with Salix. Starting on 1 July 2019, in addition to the gastroenterology, colorectal surgery, and proctology segments, Salix will have the exclusive right to co-promote the CLD indication for Dopetelet to the hepatology and interventional radiology segments. Dova will continue to pay Salix a commission based on a percentage of net sales in these specialties, which will be in the mid-thirties beginning on July 1, 2019. In addition, the co-promotion agreement was extended to September 2023.