FDA approves application to expand Doptelet for autoimmune bleeding disorder

The FDA approved a supplemental new drug application to expand the use of Doptelet to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who had an insufficient response to a previous treatment, according to a press release.

The FDA previously approved Doptelet (avatrombopag, Dova Pharmaceuticals) for the treatment of thrombocytopenia in adults with chronic liver disease 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 [immune thrombocytopenic purpura (ITP)] in adult patients who have had an insufficient response to a previous treatment,” David Zaccardelli, PharmD, president and CEO of Dova, said in the release. “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.”

Dova also announced that avatrombopag will be priced similarly to other thrombopoietin receptor agonists (TPO-RAs) used to treat ITP and that the company will continue to offer patient assistance and co-pay programs.

“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,” Caroline Kruse, president and CEO of the Platelet Disorder Support Association, said in the release. “That’s why having additional treatment options are so important. 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 company expects to launch avatrombopag commercially for ITP in mid-July 2019.

Reference: www.dova.com