J&J Boosts Neuroscience Pipeline with ITCI Acquisition, FDA Approves Spravato Monotherapy for TRD
Key Insights
Johnson & Johnson (J&J (search)) is set to acquire Intra-Cellular Therapies (ITCI) for $14.6 billion, adding Caplyta for bipolar disorder (search) and schizophrenia (search) to its neuroscience pipeline.
The FDA has approved J&J (search)'s Spravato as a monotherapy for treatment-resistant depression (search) (TRD (search)), based on positive data from the phase IV TRD4005 study.
AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) received FDA priority review for a lung cancer (search) indication and was approved for previously treated breast cancer (search).
Johnson & Johnson (J&J (search)) is making significant strides in expanding its neuroscience portfolio and oncology offerings. The company is set to acquire Intra-Cellular Therapies (ITCI) for $14.6 billion, while also receiving FDA approval for Spravato as a monotherapy for treatment-resistant depression (search) (TRD (search)). Meanwhile, AstraZeneca and Daiichi Sankyo saw their drug datopotamab deruxtecan gain FDA approval for breast cancer (search) and priority review for lung cancer (search).
J&J to Acquire Intra-Cellular Therapies
J&J (search)'s acquisition of Intra-Cellular Therapies will add Caplyta, a drug approved for the treatment of bipolar I and II depression and schizophrenia (search), to its neuroscience pipeline. The offer price of $132.00 per share represents a premium of almost 40% to ITCI’s closing price on January 10. ITCI has also filed a supplemental new drug application (sNDA) with the FDA seeking approval of Caplyta as an adjunctive treatment for major depressive disorder (search). Additional phase III studies are ongoing on Caplyta in other mental health disorders.
The acquisition will also include Intra-cellular Therapeutics’ other central nervous system candidates, including ITI-1284, which is in phase II development for generalized anxiety disorder and Alzheimer’s disease (search)-related psychosis and agitation.
Spravato Approved as Monotherapy for TRD
The FDA has approved Spravato (esketamine) nasal spray as a monotherapy for adults living with treatment-resistant depression (search) (TRD (search)). This approval expands Spravato's indication, as it was previously approved only in combination with an oral antidepressant for TRD and for depressive symptoms in adults with major depressive disorder (search) (MDD (search)) with acute suicidal ideation or behavior. The approval was based on data from the phase IV TRD4005 study. Spravato is now the first and only monotherapy approved for treating MDD in adults who have had an inadequate response to at least two oral antidepressants and are considered to have TRD.
Other Notable Developments
J&J (search) also announced that the FDA accepted for review its new drug application (NDA) for TAR-200, an intravesical drug-releasing system for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (search) (HR-NMIBC). The application was accepted for FDA’s real-time oncology review and was based on data from the phase IIb SunRISe-1 study.
AstraZeneca and Daiichi Sankyo's novel TROP2 (search)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan or Dato-DXd, received FDA approval for breast cancer (search) and priority review for a lung cancer (search) indication.