A Medical Device Daily
Biopure (Cambridge, Massachusetts) said that it had recently met with the FDA to discuss the compassionate use protocol submitted by the company in July. At the FDA’s suggestion, the company intends to submit a protocol for a Phase II randomized trial for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia, including alloantibody anemia but excluding sickle cell anemia. Hemopure has been used previously, on a compassionate use basis, to treat patients with these conditions.
The proposed patient group was included in the compassionate use protocol previously proposed to the FDA. A study protocol for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia would be in place of that compassionate use protocol. Biopure may continue to work with the FDA on compassionate use cases through single patient INDs that are requested from treating physicians.
Autoimmune hemolytic anemia is a group of disorders characterized by a malfunction of the immune system that produces antibodies to the patient’s red blood cells attacking them as if they were substances foreign to the body. This group of disorders is uncommon, can occur at any age and affects women more often than men.
Biopure makes oxygen therapeutics that are intravenously administered to deliver oxygen to the body’s tissues.