Firm will reformulate Leukine to eliminate EDTA and in the interim, will establish a special access program to provide lyophilized Leukine.
Bayer HealthCare Pharmaceuticals reports that it will withdraw the liquid formulation of its myeloid growth factor, Leukine®, marketed in the U.S. This decision was made following discussions with the FDA in light of an increase in spontaneous reports of adverse reactions including fainting.
Leukine is approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with acute myelogenous leukemia (AML). It is also used to prolong survival of patients with bone marrow graft failure or engraftment delay.
The reported adverse reactions are correlated with the liquid Leukine 500 µg vial, which contains EDTA (edetate disodium), according to Bayer. Hence, the company plans to reformulate the liquid Leukine to eliminate EDTA. In the meantime, Bayer will increase supplies of lyophilized Leukine, which does not contain EDTA.
The firm will establish a special access program for the currently marketed lyophilized Leukine 250 µg vial. It will be designed to prioritize the supply of the lyophilized Leukine for patients with AML and those who are experiencing bone marrow transplantation engraftment failure or delay. Through the program, Leukine therapy will continue to be supplied to patients participating in clinical studies.
