The Week in Review: January 13-17

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This week, Psychiatric Times discussed a wide variety of psychiatric issues and industry updates, from new FDA designations to study results.

Johnson & Johnson Acquired Intra-Cellular Therapies

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Johnson & Johnson announced a $14.6 billion acquisition of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders. The acquisition includes lumateperone (Caplyta), a US Food and Drug Administration (FDA) approved treatment for schizophrenia and bipolar disorder. A supplemental new drug application to the FDA for Caplyta as an adjunctive treatment for adults with major depressive disorder.

Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies for $132.00 per share, and the closing is expected to happen in late 2025. Continue reading.

FDA Grants Breakthrough Device Designation to pTau 217 Blood Test for Alzheimer Disease

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The FDA has granted Breakthrough Device Designation to Spear Bio’s pTau 217 blood test for Alzheimer’s disease. The test offers a noninvasive diagnostic alternative to traditional methods like positron emission tomography and lumbar punctures. pTau 217 is a phosphorylated fragment of the protein tau and a biomarker that has shown the ability to distinguish Alzheimer disease from its other neurodegenerative disorder peers. Utilizing Spear Bio’s Successive Proximity Extension Amplification Reaction (SPEAR) technology, it enhances biomarker detection accuracy, enabling earlier and more accessible diagnosis. This designation highlights its potential in improving Alzheimer’s diagnostics and patient outcomes. Other companies, including Roche and Quanterix, have also developed similar pTau 217 tests. Continue reading.

FDA Accepts Biologics License Application for Lecanemab-irmb

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The FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, a subcutaneous autoinjector for Alzheimer’s disease. Designed for weekly at-home maintenance dosing, it has the potential to simplify treatment and reduce hospital visits. Data from the Clarity study showed 14% greater reduction in amyloid plaques compared to intravenous administration. If approved, lecanemab-irmb would be the first subcutaneous Alzheimer’s treatment. The Prescription Drug User Fee Act action date is set for August 31, 2025. Continue reading.

Study Links Divorce to Genetic Predispositions for Psychiatric Disorders

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A Rutgers Health study found that individuals with higher genetic predispositions for psychiatric disorders, such as depression and anxiety, are more likely to experience divorce. Analyzing data from 2.8 million Swedish residents, researchers discovered that those who divorced had higher genetic risk scores than those in stable marriages. Women exhibited higher genetic risk scores across all disorders. Researchers found that individuals who stay remarried and maintained a stable second marriage showed lower genetic risk scores than those who divorced again or never married. The study suggests that genetic factors may influence divorce risk through traits like impulsivity or emotional instability. Continue reading.

Disappointing Data From Phase III CONNEX for Iclepertin in Addressing Cognition Impairment in Schizophrenia

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Data from the Phase III CONNEX study found that iclepertin, an investigational drug for cognitive impairment in schizophrenia, did not show significant improvement compared to placebo. Despite these disappointing results, the drug was well tolerated. “While these findings are disappointing, we remain dedicated to finding effective solutions for those living with serious mental illnesses,” Shashank Deshpande, member of the board of Managing Directors and head of Human Pharma at Boehringer Ingelheim, said. Iclepertin (BI 425809) is an investigational oral inhibitor of glycine transporter 1 (GlyT1) thought to influence brain biology and address cognition deficits in schizophrenia and potentially other disorders. The CONNEX-3 trial was double-blind, placebo-controlled study evaluating iclepertin’s safety and efficacy in stable schizophrenia patients. Addressing cognitive deficits in schizophrenia remains a major unmet need. Continue reading.