The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study

A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo

Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson's nipocalimab has received this designation

If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage

RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX®  subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220) of DARZALEX FASPRO® as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.1

New data for investigational nipocalimab in Sjögren's Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session

Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session

Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation

A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo

TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn's disease (CD), pending FDA approval

PHILADELPHIA, Oct. 28, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from the Phase 3 GRAVITI study of TREMFYA® (guselkumab), the first and only IL-23 inhibitor, demonstrating robust results in subcutaneous (SC) induction and maintenance therapy. The findings demonstrated significant clinical remission and endoscopic response at 48 weeks in adults with moderately to severely active CD.1 These results are among the 14 Johnson & Johnson abstracts presented at the American College of Gastroenterology (ACG) 2024, October 25-30.

First-of-its-kind Phase 3b study shows TREMFYA® achieved statistical significance across all primary and secondary endpoints in low body surface area psoriasis with special site involvement

Johnson & Johnson launches library of clinical images from Phase 3b VISIBLE study to enhance clinical decision making for people across all skin tones living with moderate to severe plaque psoriasis

LAS VEGAS, Oct. 25, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that treatment with TREMFYA® (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment. Sensitive or highly visible areas affected by PsO, including the scalp, face, skin folds and genitals, are considered "special sites" and can have significant impact on patients' daily lives, yet systemic treatment is infrequently provided and this group of patients remains largely undertreated.1 Data from the Phase 3b SPECTREM study, the first prospective, large-scale, randomized-controlled, double-blind clinical study to measure skin clearance and other treatment outcomes in low BSA moderate PsO with involvement across four special sites (scalp, face, skin folds and genitals) and previous topical treatment failure, were presented today at the 2024 Fall Clinical Dermatology Conference.

TITUSVILLE, N.J., Oct. 24, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 23 abstracts featuring new real-world and clinical trial data from across its neuropsychiatry portfolio and pipeline will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress), taking place October 29 to November 2 in Boston, Massachusetts. Presentations include new data supporting the safety and efficacy of SPRAVATO® (esketamine) CIII nasal spray and the Company's innovative portfolio of long-acting injectables (LAIs) for schizophrenia, as well as data highlighting the significant burden people living with major depressive disorder (MDD) and schizophrenia often face.

First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied 

SAVANNAH, Ga., Oct. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents (aged 12 – 17 years) living with generalized myasthenia gravis (gMG). Study participants who were treated with nipocalimab plus standard of care (SOC) achieved sustained disease control as measured by the primary endpoint of immunoglobulin G (IgG) reduction from baseline over 24 weeks, and secondary endpoints of improvement in MG-ADLb and QMGc scores. These Phase 2/3 data will be featured in an oral presentation (Abstract #MG100) at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, where Johnson & Johnson will present 25 abstracts.  

TREMFYA® is now U.S. FDA-approved for ulcerative colitis and under review for Crohn's disease

TREMFYA® is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn's disease, inclusive of those who are biologic-naïve and biologic-refractory 

Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA® 

VIENNA, Austria, Oct. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced TREMFYA® (guselkumab) data in both Crohn's disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa.1,2 These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of TREMFYA® in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of TREMFYA® in adults with moderately to severely active UC. These findings are among 19 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2024. TREMFYA® is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA). 

Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to enzalutamide

LISBON, Portugal, Oct. 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA® (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). Presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal, on October 2 (Abstract #P31), this study of nearly 4,000 patients represents the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC.

Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility

New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint

RARITAN, N.J., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.  

The new full visual range IOL*1 delivers exceptional distance vision2 and 14% smaller readable print size vs PanOptix3 †.

93% of patients become free from glasses at all distances.#4 ‡

TECNIS Odyssey IOL offers higher tolerance to residual refractive errors, enabling surgeons to deliver consistent and reliable patient outcomes.5¶

JACKSONVILLE, Fla., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson§, a global leader in eye health, has announced it's expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. The new full visual range IOL*1 offers patients unmatched continuous full range of vision‖¶¶6, so they can see clearly from far to near and in between, minimizing their need for glasses 3,6 †‖# . TECNIS Odyssey IOL is built on the TECNIS platform, providing two-times better contrast in low lighting than PanOptix.7,8 † In addition, TECNIS Odyssey IOL patients are able to read 14% smaller print on average than PanOptix IOL patients2 † and 93% reported no or mild halos, glare, or starbursts one month after surgery9.

45 percent reduction in risk of death achieved with CARVYKTI® after three-year follow-up in landmark CARTITUDE-4 study 

Data featured in a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today long-term results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI® (ciltacabtagene autoleucel) significantly extended overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), reducing the risk of death by 45 percent versus standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 With these data, CARVYKTI® is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line.1 Findings were featured as a late-breaking oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting (Abstract #OA-65).1

Minimal residual disease (MRD)-negativity rate of 10-5 more than doubled by 12 months with DARZALEX FASPRO® in maintenance therapy compared to lenalidomide alone, resulting in improvement in 30-month progression-free survival

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from three studies highlighting clinical efficacy of DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in maintenance regimens. Data from the Phase 3 AURIGA study show DARZALEX FASPRO® plus lenalidomide (D-R) maintenance therapy following autologous stem cell transplant (ASCT) significantly increases MRD-negative conversion rates at 12 months compared to lenalidomide (R) maintenance alone in patients with newly diagnosed multiple myeloma (NDMM). DARZALEX FASPRO® plus lenalidomide maintenance therapy also demonstrated a potential benefit in progression-free survival (PFS) with no new safety concerns.1 Data were featured in an oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting (Abstract #OA – 45).

Study of the first and only subcutaneous quadruplet regimen demonstrates 60.9 percent improvement in minimal residual disease (MRD)-negativity and 43 percent reduction in the risk of progression or death

Phase 3 CEPHEUS study results presented in late-breaking oral presentation at the International Myeloma Society (IMS) Annual Meeting

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today results from the Phase 3 CEPHEUS study demonstrating a significant clinical improvement with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible (TIE) or for whom transplant was not planned as initial therapy (transplant deferred). The data showing significant improvement in minimal residual disease (MRD) negativity rate, progression-free survival (PFS) and complete response (CR) or better rate, were featured as a late-breaking oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting (Abstract #OA — 63).

Data from the investigational Phase 1b RedirecTT-1 study demonstrate a safety profile consistent to TALVEY® and TECVAYLI® monotherapies

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b RedirecTT-1 study evaluating the first-ever bispecific antibody combination of TALVEY® (talquetamab-tgvs), the first and only FDA-approved bispecific targeting GPRC5D, and TECVAYLI® (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific therapy, showing high response rates and durable responses, with a consistent safety profile to each monotherapy, in patients with relapsed or refractory multiple myeloma (RRMM) who were triple-class exposed, including those with extramedullary disease. These data were featured in an oral presentation at the 2024 International Myeloma Society Annual Meeting (Abstract # OA – 03).

Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody

Safety profile, including infection rates, similar to TALVEY® and DARZALEX FASPRO® monotherapies

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY® (talquetamab-tgvs) with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination. These data were featured in an oral presentation at the 2024 International Myeloma Society Annual Meeting (Abstract #OA – 01).

Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall

RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).1

TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence

BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and scheduled for radical cystectomy (RC).1 These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA84).

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive

BARCELONA, Spain, Sept. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA85).

Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease

New results show potential of RYBREVANT® beyond lung cancer

BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC) who have not previously received anti-epidermal growth factor receptor (EGFR) therapy. These data were presented in a mini-oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress.1