Friday, November 7, 2025
FDA Approves Johnson and Johnson’s Caplyta for Major Depression
Caplyta is now FDA-approved for MDD treatment in adults, marking its fourth indication, including bipolar I and II depression and schizophrenia.
Phase III trials showed significant improvements in depression symptoms with Caplyta, achieving primary and secondary endpoints.
FDA’s approval of Caplyta as an adjunctive treatment to oral antidepressants for major depressive disorder in adults, expands the drug’s use to a fourth indication following positive Phase III trial results.
Johnson and Johnson announced FDA’s approval of Caplyta in combination with oral antidepressants for the treatment of major depressive disorder (MDD) in adults.1 This approval marks Caplyta’s fourth approved indication, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy, and is also approved for the treatment of schizophrenia in adults.1
s the potential to become a new standard of care across multiple mental health disorders, including major depressive disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "This approval is a testament to our nearly 70-year commitment of bringing innovative and differentiated therapies that redefine treatment expectations and introduce the possibility of remission to patients living with some of today's most prevalent and debilitating mental health conditions."
Why did FDA approve Caplyta?
Caplyta’s approval is based on positive results collected from two Phase III, global, double-blind, placebo-controlled trials Study 501 and 502, where both studies reached their primary and key secondary endpoints. They also provided statistically significant and clinically meaningful improvements in depression symptoms compared to an oral antidepressant plus placebo, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression Scale-Severity index (CGI-S) scores.1 In Study 501 a significant separation in total MADRS score was seen between Caplyta and placebo, along with similar results in Study 502 at six weeks.1 According to a news release from Johnson and Johnson, separation from placebo was seen as early as one week in Study 501 and two weeks in Study 502, along with significant reductions in key secondary endpoint of mean changes in total CGI-S scores from baseline in Study 501 at six weeks.
Caplyta’s safety profile remained consistent with the existing body of clinical data in its schizophrenia and bipolar depression I and II indications, with no new safety concerns being identified. The most common side effects of Caplyta include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea.1
Why did Johnson and Johnson focus on developing a MDD indication of Caplyta?
With MDD or clinical depression being one of the most common psychiatric disorders affecting an estimated 22 million American adults, oral antidepressants may only offer relief for a select few patients. 2 in 3 people living with MDD continue to experience residual symptoms despite treatment, significantly impacting overall quality of life.1 According to a press release from Johnson and Johnson, MDD holds a significant economic burden, while also being the leading cause of disability in the U.S.
"Depression is a complex disorder that affects each person differently, underscoring the urgent need for a range of effective and well-tolerated treatment options," said Roger S. McIntyre, M.D., FRCPC, professor of psychiatry and pharmacology, University of Toronto. "For people who are still experiencing lingering depressive symptoms while on an antidepressant, adding Caplyta to a patient's treatment regimen may offer early improvement, with the potential for remission, the ultimate goal of treatment."
https://www.pharmexec.com/view/fda-approves-johnson-caplyta
FDA approves J&J's Darzalex as 1st treatment for smoldering multiple myeloma
For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition develops into multiple myeloma.
The FDA has approved Johnson & Johnson’s Darzalex subcutaneous formulation to treat patients with smoldering multiple myeloma (SMM) that is at a high risk of developing into multiple myeloma.
Before Thursday’s approval, doctors could only monitor patients with SMM, which is an asymptomatic intermediate disease state, in hopes of catching early signs of the condition’s development into cancerous MM.
More than 35,000 people were estimated to be diagnosed with myeloma in the U.S. in 2024, with about 15% of new diagnoses classified as SMM, according to J&J. About 50% of high-risk SMM cases are likely to progress into active MM within two to three years.
The approval was based on results from a phase 3 trial called Aquila, which showed that Darzalex Faspro significantly delayed disease progression to MM or death by 51% versus basic monitoring. The median progression-free survival time was not reached in the Darzalex arm, versus a median result of 41.5 months in the control group.
The FDA initially had hesitations about the company’s application, raising doubts about whether more mature patient survival data were needed to determine Darzalex’s benefit-risk profile for an asymptomatic precursor condition, especially since the CD38 antibody is well established as a powerful treatment for multiple myeloma.
In approving Darzalex, the FDA followed the recommendation of an external advisory committee. Advisors to the agency said they were convinced by results from the Aquila trial, including a preliminary but clear sign of a trend toward improved survival, although they still urged J&J to follow the study to further characterize Darzalex’s profile in SMM.
A step ahead of the FDA, European regulators had already approved Darzalex in SMM in July.
The approval of Darzalex in SMM offers drugmakers some relief, because the drug’s proposed use had previously drawn criticism from Vinay Prasad, M.D., before he became the FDA’s chief medical and scientific officer as well as director of the Center for Biologics Evaluation and Research. Prasad has been known as a proponent of overall survival serving as the most important endpoint to determine a drug’s approvability. In a December 2024 post, he criticized the lack of patient exposure to Darzalex as a subsequent treatment for patients in Aquila’s control arm.
Although Darzalex’s review fell within the purview of Richard Pazdur, M.D., who leads the FDA’s Oncology Center of Excellence, Prasad’s chief medical and scientific officer title at the agency theoretically could give him power to intervene.
The Darzalex approval in SMM serves as proof that Prasad is “taking a more holistic approach to some approvals,” Everecore ISI analyst Cory Kasimov wrote in a Thursday note.
In the MM field, Kasimov viewed the nod as a positive sign for Arcellx and Gilead Sciences’ upcoming accelerated approval bid for their BCMA CAR-T therapy anito-cel. Since the partners plan to seek accelerated approval based on the phase 2 IMMagine-1 trial, the drug won’t have randomized OS data to back its case. As a cell therapy, anito-cel lands with Prasad’s department, with expected meaningful input from Pazdur’s team as well.
Eli Lilly's weight-loss therapy Mounjaro tops India drug sales by value in October
Eli Lilly's weight-loss therapy Mounjaro became India's top-selling drug by value in October, data showed on Friday, overtaking GSK's widely used antibiotic Augmentin, as demand surges in the world's most populous nation.
The U.S. drugmaker's popular injectable therapy raked in 1 billion rupees ($11.38 million) in October, research firm Pharmarack said. That outpaced Augmentin sales of 800 million rupees last month.
By volume, Augmentin was way higher than Mounjaro with 5,784 units sold during October, compared to just 85 units sale of Mounjaro, which is sold at a much higher price point.
The news comes as India becomes a key battleground for drugmakers, looking to grab a slice of the burgeoning weight-loss treatment market, which some analysts predict will generate $150 billion a year or more by the end of the decade.
Mounjaro, which helps control blood sugar and slow digestion, saw its sales double within months of its March launch in India, ahead of rival Novo Nordisk's Wegovy, which entered the market in June.
The drug has generated 3.33 billion rupees in revenue till the end of October, according to Pharmarack.
"Mounjaro's consumption in India by volume was 10 times more than Wegovy in October," Sheetal Sapale, Pharmarack's Vice President (Commercial), told the media on Friday.
While Lilly sold 262,000 Mounjaro units last month, Novo Nordisk sold 26,000 Wegovy units.
Both belong to a class of therapies known as GLP-1 receptor agonists, which help patients feel fuller for longer and are increasingly used to treat obesity and diabetes.
The rapid uptake of these drugs reflects growing demand for weight-loss treatments in India, where lifestyle diseases are on the rise.
Lilly also signed a deal with Indian drugmaker Cipla last month to sell Mounjaro under a separate brand name.
Globally, Lilly and Novo have seen soaring demand for their anti-obesity therapies, prompting supply constraints and pricing scrutiny.
Both companies have struck a deal with the Trump administration to reduce prices of their GLP-1 drugs for U.S. government programs, aiming to improve access amid mounting pressure over affordability.
Wegovy's active ingredient semaglutide will lose patent protection in India in March 2026 and that has prompted many Indian drugmakers to develop their own versions of the wildly in-demand drug.