trending Market Intelligence /marketintelligence/en/news-insights/trending/54s8emvib6rjje99nx47aq2 content esgSubNav
In This List

Dova seeks US FDA approval for Doptelet to treat bleeding disorder

Blog

Insight Weekly: Unease roils markets; US likely to slip into recession; firms' cash ratios fall

Blog

Insight Weekly: Bank boards lag on gender parity; future of office in doubt; US LNG exports leap

Blog

Insight Weekly: Job growth faces hurdles; shale firms sit on cash pile; Africa's lithium future

Blog

Insight Weekly: Loan growth picks up; US-China PE deals fall; France faces winter energy crunch


Dova seeks US FDA approval for Doptelet to treat bleeding disorder

Dova Pharmaceuticals Inc. submitted an application with the U.S. Food and Drug Administration seeking approval for Doptelet to treat a bleeding disorder.

The company is seeking approval to treat immune thrombocytopenia, or ITP, which can lead to excessive bruising and bleeding due to low levels of platelets in the blood.

The U.S. FDA previously granted Doptelet an orphan drug designation for potentially treating ITP, the company said in a Sept. 4 news release.

Doptelet received the FDA's nod in May to treat thrombocytopenia, a condition characterized by an abnormally low platelet count, in adult patients with chronic liver disease.

The ITP application includes data from a phase 3 study, which showed that the drug improved platelet count, as well as two phase 2 studies and two late-stage studies that supported the recent FDA approval.