Leukine is an immuno-stimulant that promotes the growth and activation of a broad range of white blood cells important in activating the body’s immune response to fight infections. Leukine is used to treat or prevent severe and life-threatening infections and is the only immune modulator approved by the FDA for the treatment of acute myelogenous leukemia (AML) in older patients and for use in both allogeneic and autologous bone marrow transplantation.
PTx will support the development of Leukine for new indications, including for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). Data presented at the 2016 annual meeting of the American Society of Hematology, demonstrated Leukine’s ability to increase survival in non-human primates exposed to myelosuppressive doses of radiation without supportive whole blood transfusions or individualized antibiotics. A supplemental biologics licensing application (sBLA) was filed in September of 2017 with the FDA requesting approval of Leukine for the treatment of H-ARS. In December, the application was granted Priority Review with a PDUFA date of March 29, 2018.
Leukine is also in development for its potential to improve survival and reduce adverse events in combination with leading immuno-oncology therapies.
“The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections,” said Robert Mulroy, CEO of PTx.
PTx plans to provide commercial and medical support of Leukine in the United States and explore commercialization opportunities outside the U.S.
Source: Partner Therapeutics, edited for context and format by Global Biodefense.