Dova Pharmaceutics has submitted a supplemental New Drug Application to the US FDA on behalf of Doptelet® (avatrombopag), which is being researched as an investigational treatment of immune thrombocytopenia in patients that had an insufficient response to previous treatment. For more detailed information the source press release can be found here, at Globe Newswire.
About Immune Thrombocytopenia
Immune thrombocytopenia (ITP) is a rare autoimmune bleeding disorder. It is typically associated with low levels of platelets; red blood cells involved in blood clotting. As outlined by NORD, some people with ITP may experience symptoms such as frequent bruising, small red dots on the skin, nosebleeds, and gum bleeding, amongst others. For some patients, the frequent bleeding may lead to anaemia, which can cause fatigue and weakness.
About Doptelet (Avatrombopag)
Doptelet is a drug that is being developed as an investigational treatment for patients with ITP who have has an insufficient response to previous treatment. It is a thrombopoietin receptor antagonist, and has been awarded Orphan Drug Designation. The FDA approved Doptelet in March this year for adult patients with thrombocytopenia who have chronic liver disease and who are scheduled to undergo a procedure.
Research into Doptelet
The supplemental new drug application submitted for Doptelet is based on positive results of the safety and efficacy of the drug in patients with ITP in clinical research.
A Phase 3 clinical trial in patients with ITP that compared Doptelet to a placebo found that the drug met the primary and secondary efficacy endpoints, both of which were linked to platelet count levels. The results of this study are expected to be published soon in the British Journal of Haematology.
In addition to this study, Doptelet has been investigated for use on ITP in two Phase 2 trials.
For more information about this drug, the studies, and the sNDA, you can view the original press release by clicking here.