FDA News

FDA approves Doptelet for chronic immune thrombocytopenia

The FDA expanded the approval of avatrombopag to include treatment of adults with chronic immune thrombocytopenia who had insufficient response to previous treatment.

Avatrombopag (Doptelet, Dova Pharmaceuticals) — an oral thrombopoietin receptor agonist administered with food — already had been approved for treatment of thrombocytopenia among adults with chronic liver disease who are scheduled to undergo a procedure.

The FDA based the chronic immune thrombocytopenia (ITP) indication in part on results of a phase 3 study that showed avatrombopag administration resulted in a platelet count of at least 50,000 per µL at day 8 of therapy for most patients with chronic immune thrombocytopenia. The agent appeared superior to placebo for maintaining platelet counts in the target range during the 6-month target period.

“Dova is pleased to provide Doptelet to patients and physicians in the United States for the treatment of ITP in adult patients who have had an insufficient response to a previous treatment,” David Zaccardelli, PharmD, said in a company-issued press release. “In addition to offering patients with immune thrombocytopenia a new treatment option, we expect Doptelet will also address an important unmet medical need in the market.”

Chronic ITP — which affects approximately 60,000 adults in the United States — is a rare autoimmune bleeding disorder characterized by low numbers of platelets. The condition leads to severe bleeding and excessive bruising.

“[Patients with ITP] 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,” Caroline Kruse, president and CEO of the Platelet Disorder Support Association, a patient advocacy organization dedicated to patients with ITP, said in the release. “We are thrilled to have a new, oral thrombopoietin receptor agonist available for adult patients with ITP. Every new treatment provides more choices and new hope to our community.”

The most common adverse reactions among patients with ITP treated with avatrombopag include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.

The FDA expanded the approval of avatrombopag to include treatment of adults with chronic immune thrombocytopenia who had insufficient response to previous treatment.

Avatrombopag (Doptelet, Dova Pharmaceuticals) — an oral thrombopoietin receptor agonist administered with food — already had been approved for treatment of thrombocytopenia among adults with chronic liver disease who are scheduled to undergo a procedure.

The FDA based the chronic immune thrombocytopenia (ITP) indication in part on results of a phase 3 study that showed avatrombopag administration resulted in a platelet count of at least 50,000 per µL at day 8 of therapy for most patients with chronic immune thrombocytopenia. The agent appeared superior to placebo for maintaining platelet counts in the target range during the 6-month target period.

“Dova is pleased to provide Doptelet to patients and physicians in the United States for the treatment of ITP in adult patients who have had an insufficient response to a previous treatment,” David Zaccardelli, PharmD, said in a company-issued press release. “In addition to offering patients with immune thrombocytopenia a new treatment option, we expect Doptelet will also address an important unmet medical need in the market.”

Chronic ITP — which affects approximately 60,000 adults in the United States — is a rare autoimmune bleeding disorder characterized by low numbers of platelets. The condition leads to severe bleeding and excessive bruising.

“[Patients with ITP] 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,” Caroline Kruse, president and CEO of the Platelet Disorder Support Association, a patient advocacy organization dedicated to patients with ITP, said in the release. “We are thrilled to have a new, oral thrombopoietin receptor agonist available for adult patients with ITP. Every new treatment provides more choices and new hope to our community.”

The most common adverse reactions among patients with ITP treated with avatrombopag include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.