Otsuka Pharmaceutical (OTCPK:OTSKF) submitted a marketing application to the Pharmaceuticals and Medical Devices Agency in Japan, seeking approval for difamilast (OPA-15406), a phosphodiesterase 4 (PDE4) inhibitor in patients with atopic dermatitis.
FAIRFIELD, N.J., Sept. 18, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced that the Company received a Type C Meeting Written Response from the U.S. Food and Drug Administration (FDA) regarding MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the FDA response, Medimetriks is preparing to conduct a single pivotal trial in the U.S. for MM36's New Drug Application (NDA), which will be supported by data from already-completed Phase 3 trials conducted in Japan.