ICER’s report says evidence for schizophrenia therapy KarXT promising, but inconclusive

US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised  Evidence Report assessing the comparative clinical effectiveness and value of KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics (Nasdaq: KRTX) for the treatment of schizophrenia.

KarXT was a leading attraction for US pharma giant Bristol Myers Squibb (NYSE: BMY), which announced a $12.7 billion offer to acquire Karuna in December, which is expected to close in the first half of this year. According to Mizuho Securities analysts, KarXT's annual sales could exceed $6 billion if it is approved for all its potential uses.

“Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves,” said the ICER’s chief medical officer, Dr David Rind. “Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited,” he noted.