Mallinckrodt plc affirmed enrolling first patient in the company’s Phase 4, multi center, randomized, double-blind, placebo-controlled pilot study to facilitate evaluation of the efficacy of H.P. Acthar Gel as a therapy option in patients grappling with pulmonary sarcoidosis. U.S FDA assents to H.P. Acthar Gel for the respiratory condition symptomatic sarcoidosis, one of 19 indications.
Dr. Robert Baughman, M.D., Professor in the Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio claimed ” I am pleased that the first patient has been enrolled in this important Phase 4 study, the results of which may potentially provide evidence to further support Acthar as a treatment option in appropriate symptomatic sarcoidosis patients.”
Tunde Otulana, M.D., Chief Medical Officer at Mallinckrodt said “”We believe this exploratory evaluation of the more challenging patients who may still have disease activity after previous therapies can potentially help physicians better understand which individuals may benefit from the drug as a treatment alternative.”