Intra-cellular triples on schizophrenia approval


These days clinical trials seem to be less a means of ensuring safety and efficacy, and more a formality to be completed before the FDA automatically awards approval. The latest beneficiary of the agency’s soft touch is Intra-cellular Therapeutics, whose stock climbed 193% yesterday following approval of lumateperone for schizophrenia, despite the agent having been linked with toxicity in animals and failing to beat placebo in one of its two registrational studies. The drug will be launched as Caplyta, carrying a black box warning for patients with dementia-related psychosis, but this is usual for antipsychotics and might not be too off-putting to doctors, particularly in conjunction with Caplyta’s relatively good safety profile. The question now is what the move means for other neurological agents approaching the FDA. Perhaps Sage’s SAGE-217 might defy its miss in the Mountain study and obtain approval for depression; Acadia's Nuplazid, which failed in schizophrenia but hit in dementia-related psychosis, might also gain the green light for one or both indications. Presumably this is also a positive sign for the industry’s biggest CNS cliffhanger – though with a deeply complex and opaque dataset approval for Biogen’s Alzheimer’s candidate aducanumab might still be a long shot.

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