Genentech, a member of the Roche Group, said hemophilia A occurs when a blood clotting protein called factor VIII is either not present in required amounts or is defective.
ACE910 is an investigational humanized bispecific monoclonal antibody engineered to bind IXa and X factors at a time.
The company said it is designed to promote blood coagulation in hemophilia A patients, regardless of whether they have developed inhibitors to factor VIII.
ACE910 is administered subcutaneously once weekly. The development program of the medicine is evaluating its potential to help overcome some of the clinical challenges experienced in hemophilia care like the development of factor VIII inhibitors and the need for venous access.
Chugai Pharmaceutical created ACE910, which is being co-developed by Genentech.
Genentech chief medical officer and head of global product development Sandra Horning said: "People with hemophilia A may require regular and frequent infusions of replacement clotting factor to reduce the risk of dangerous bleeding, and they can develop inhibitors that make replacement ineffective.
"We are pleased that the FDA has granted breakthrough therapy designation for ACE910, recognizing an unmet need for patients with inhibitors and the promise of these early data. Genentech has been developing antibody treatments for people with blood disorders for over 20 years, and we are excited to expedite the development of a potential new treatment for hemophilia A."