Allergan planning sNDA for cariprazine in bipolar I depression after Phase III readout

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said cariprazine (MP-214, RGH-188) met the primary endpoint in the Phase III RGH-MD-54 trial to treat bipolar I depression. Allergan plans to submit an sNDA to FDA for the indication in 2H18.

Cariprazine is already approved in the U.S. as Vraylar to treat schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. The drug is approved in the EU as Reagila to treat schizophrenia...