The Food and Drug Administration (FDA) has granted Orphan Drug designation to avatrombopag for the potential treatment of chemotherapy-induced thrombocytopenia, a complication that may lead to chemotherapy dose delays and regimen changes.
Avatrombopag, a thrombopoietin receptor agonist, is currently approved under the brand name Doptelet (Dova Pharmaceuticals) for the treatment of thrombocytopenia in patients with chronic liver disease and for those with chronic immune thrombocytopenia. The Company is currently recruiting for a phase 3 clinical study to evaluate the efficacy and safety of avatrombopag in patients with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung and bladder cancer.
The FDA’s Orphan Drug designation is granted to treatments for rare diseases that affect ≤200,000 individuals. “The granting of ODD highlights the significant need for a drug that could improve chemotherapy-induced low platelet counts and thereby enable patients to better adhere to their chemotherapy regimen,” said Mahmood Ladha, President and Head of Dova.
For more information visit Dova.com.