Eisai Inc. announced that the FDA expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both Fycompa tablet and oral suspension formulations. “Eisai is working tirelessly to…
Eisai Receives FDA Priority Review Designation For Fycompa
The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for Priority Review for its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages two to less than 12 years). The submission also proposes a pediatric indication for adjunctive use…
Lenvima-Keytruda Combo Granted Breakthrough Therapy Status For Renal Cell Carcinoma
Eisai and Merck receive breakthrough therapy designation from FDA for Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma. Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase…
