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NEW YORK - Johnson & Johnson (NYSE:JNJ) announced on Tuesday the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for CAPLYTA (lumateperone) for the prevention of relapse in schizophrenia.
The submission is supported by Phase 3 trial data showing CAPLYTA reduced the risk of relapse by 63 percent compared to placebo. The study demonstrated significantly longer time to relapse during the 26-week double-blind treatment phase for patients receiving CAPLYTA versus those on placebo.
CAPLYTA is already FDA-approved for treating schizophrenia and depressive episodes associated with bipolar I or II disorder, both as monotherapy and as adjunctive therapy with lithium or valproate.
"Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Global Therapeutic Area Head of Neuroscience at Johnson & Johnson Innovative Medicine, according to the company’s press release.
The Phase 3 trial was a multicenter, double-blind, placebo-controlled, randomized withdrawal study. Patients who stabilized during an 18-week open-label phase were randomized to continue CAPLYTA or switch to placebo for up to 26 weeks.
Schizophrenia affects an estimated 2.8 million adults in the United States. When left untreated, the disorder can lead to episodes of psychosis and hallucinations. On average, adults with schizophrenia experience nine relapses in less than six years. For investors tracking this development, InvestingPro analysis shows JNJ maintaining healthy profit margins of 68.9% and strong cash flows, suggesting robust potential for its pharmaceutical pipeline. Get access to detailed financial analysis and 7 additional exclusive ProTips about JNJ with an InvestingPro subscription.
The most commonly reported adverse event in the study that occurred at a rate greater than or equal to 5% and twice the rate of placebo was headache. No new safety concerns were identified during the trial.
An sNDA for CAPLYTA as an adjunctive treatment for adults with major depressive disorder is currently under FDA review. With a solid dividend yield of 3.35% and a 54-year history of consecutive dividend increases, JNJ continues to demonstrate financial stability while pursuing pharmaceutical innovations. For comprehensive insights into JNJ’s valuation and growth prospects, access the full Pro Research Report available on InvestingPro, offering expert analysis of what really matters for informed investment decisions.
In other recent news, Johnson & Johnson has made several notable announcements. The company reported new data showing its FcRn blocker, IMAAVY, demonstrated consistent and sustained disease control in patients with generalized myasthenia gravis. IMAAVY, which received FDA approval earlier this year, showed significant improvement in symptom relief compared to other treatments. In another development, Johnson & Johnson’s experimental dual-targeting CAR T-cell therapy for large B-cell lymphoma showed high response rates, with complete response rates between 75-80% in a Phase 1b study. The therapy, developed in collaboration with AbelZeta Inc., also exhibited a favorable safety profile.
Additionally, promising results were reported for the investigational drug bleximenib in treating acute myeloid leukemia, achieving an overall response rate of 82% in patients with relapsed or refractory disease. Johnson & Johnson’s Tremfya also demonstrated significant ability to inhibit joint structural damage in psoriatic arthritis patients, reducing progression by two and a half times compared to placebo. Lastly, Daniel Pinto, President of JPMorgan Chase, was elected to Johnson & Johnson’s Board of Directors, bringing over three decades of financial expertise to the company.
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