Aticaprant

Dive Brief:Johnson & Johnson won Food and Drug Administration approval to sell its drug Caplyta for patients suffering from major depressive disorder, a key step in its ambitions to make the medicine a $5 billion-a-year seller.Caplyta is already cleared to treat patients with schizophrenia and those suffering from bipolar I and II depression, conditions that affect some 13 million Americans combined. Major depressive disorder, also known as clinical depression, afflicts about 22 million Americans and two-thirds of that group dont get enough relief from current medicines, J&J said Thursday.The latest FDA approval is based on research that showed Caplyta could significantly improve depression symptoms, as well as an open-label study that found that 80% of patients responded to treatment, with 65% achieving remission. At the same time, the drug didnt cause the side effects such as low sexual desire or weight gain that often leads patients to drop off antidepressant treatments, J&J said.Dive Insight:The expanded label is a validation of J&Js $14.6 billion purchase of Intra-Cellular Therapies earlier this year. Intra-Cellular developed Caplyta and won its first approval in schizophrenia in late December 2019.As the COVID-19 pandemic swept the country in 2020, Intra-Cellular undertook a virtual launch for the drug and then consistently increased sales as TV commercials urged potential patients to Let in the Lyte.After scoring a late-stage clinical trial win in depression in 2024, Intra-Cellular executives projected that Caplyta would eventually bring in annual revenue of $5 billion, a number that surprised Wall Street and clearly intrigued J&J. The acquisition was the industrys largest to date this year and among the top 10 in the past seven years, according to BioPharma Dive data.For J&J, the expanded use of Caplyta further strengthens a stable of neuroscience drugs that includes the blockbuster Spravato, a form of ketamine given via nasal spray to treat depression. And it helps make up for the loss of an experimental drug that J&J had hoped would be a multibillion-dollar seller but failed to meet expectations. The company gave up on that medicine, aticaprant, earlier this year. '

iStock, SiyueSteuber Nipocalimab, approved as Imaavy for generalized myasthenia gravis earlier this year, failed to show significantly added benefit when used with an anti-TNFα therapy in patients with rheumatoid arthritis. Johnson & Johnson’s FcRn blocker nipocalimab showed no significant therapeutic benefit in a mid-stage rheumatoid arthritis trial, pushing the pharma to discontinue its development. J&J was testing nipocalimab plus an anti-TNFα therapy in the Phase IIa DAISY trial, enrolling more than 100 patients with moderate to severe and active disease who had already had prior treatment. The company did not provide specific data in its announcement on Thursday, only noting that DAISY “did not show sufficient evidence that the combination therapy provided significant added benefit over anti-TNFα therapy alone.” Nipocalimab is a human IgG1 monoclonal antibody that targets the neonatal Fc receptor, in turn lowering levels of IgG. The biologic won the FDA’s approval in April for the treatment of generalized myasthenia gravis, carrying the brand name Imaavy. Aside from rheumatoid arthritis, J&J is continuing to test nipocalimab in other immunology indications, including Sjogren’s disease and systemic lupus erythematosus. “We remain confident in the nipocalimab product having $5B+ potential,” J&J said in its announcement on Thursday. Even with nipocalimab’s retreat from arthritis, however, J&J continues to chip away at the disease. In July, the pharma filed a supplemental submission to the FDA, seeking to add data to the label of its therapeutic antibody Tremfya, showing that it helps prevent the progression of structural damage in patients with active psoriatic arthritis. Tremfya, which targets IL-23, was approved for this disease in 2020 . Thursday’s mid-stage stumble marks a rare miss for J&J. The pharma also suffered a late-stage flop in March for its kappa opioid receptor blocker aticaprant. Results showed “insufficient efficacy” when it was used as a treatment for patients with major depressive disorder. Otherwise, 2025 has been a good clinical year so far for J&J. The same month as its depression defeat, J&J reported that a combination regimen based on Rybrevant bested AstraZeneca’s Tagrisso in a late-stage trial of non-small cell lung cancer, leading to significantly better overall survival. Also in March 2025, J&J’s experimental IL-23 receptor blocker icotrokinra  outperformed placebo and Bristol Myers Squibb’s Sotyktu in a Phase III plaque psoriasis study. In June, J&J’s CAR T therapy JNJ-4496  achieved a 100% objective response rate in a Phase Ib trial of patients with large B cell lymphoma, with complete response rate reaching 80%.