Vanda withdraws Fanaptum MAA
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) withdrew an MAA for Fanaptum iloperidone to treat schizophrenia after EMA's CHMP requested data from the ongoing Phase III REPRIEVE trial. Vanda said the data will not be available in the allowed time frame. In December, CHMP recommended against approval of the MAA; Vanda subsequently requested a re-examination of the opinion.
Vanda said it will reassess its European regulatory strategy for Fanaptum once the data are available. Partner Novartis AG (NYSE:NVS; SIX:NOVN) is running the REPRIEVE trial, which is evaluating iloperidone to prevent relapse in schizophrenia patients. The pharma did not provide a REPRIEVE data milestone. Novartis markets the serotonin (5-HT2) receptor and dopamine receptor antagonist in the U.S. as Fanapt for the indication. ...