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October 21, 2019

New OPSUMIT® (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension

OPSUMIT, as part of a combination regimen, reduced the primary endpoint of mean pulmonary vascular resistance by 47% at week 16 compared with baseline

Innovative Medicine

October 21, 2019

Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative

In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids STELARA is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint

Innovative Medicine

October 18, 2019

Janssen Receives Positive CHMP Opinion for Spravato® (Esketamine) Nasal Spray for Adults with Treatment-Resistant Major Depressive Disorder

If approved by the European Commission, esketamine nasal spray will offer the ﬁrst new mechanism of action in 30 years to treat major depressive disorder (MDD) In the phase III clinical development programme with flexible dosing, esketamine nasal spray and a newly initiated oral antidepressant achieved superior improvement in depression symptoms, and sustained improvement in their symptoms over time compared to adults who received a placebo and an oral antidepressant1,2

Innovative Medicine

October 3, 2019

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects

Innovative Medicine

September 30, 2019

U.S. FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD

Learn about the FDA approval of Invokana, a breakthrough in treating diabetic kidney disease and reducing heart failure risk in patients with type 2 diabetes.

Innovative Medicine

September 26, 2019

Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma

Approval represents first and only FDA-approved biologic indicated for newly diagnosed patients who are eligible for a stem cell transplant Marks the seventh approved indication for DARZALEX®

Innovative Medicine

September 20, 2019

XARELTO® (rivaroxaban) Reduces Recurrent Blood Clots and Total Medical Costs in Morbidly Obese Patients

New real-world study of patients with venous thromboembolism (VTE) and morbid obesity shows safety and effectiveness of XARELTO® were similar to warfarin, with significantly less healthcare resource utilization (HRU) and total medical costs

Innovative Medicine

September 19, 2019

Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple Data Presentations at ESMO 2019

Second interim analysis from the Phase 3 SPARTAN study reporting updated overall survival results in patients with non-metastatic castration-resistant prostate cancer treated with ERLEADA® (apalutamide) Patient-reported outcomes from the Phase 3 TITAN study evaluating ERLEADA® in patients with metastatic castration-sensitive prostate cancer Interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer and biallelic DNA-repair gene defects, featured as late-breaking abstract

Innovative Medicine

September 11, 2019

New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS)

OPTIMUM Phase 3 study data presented for the first time during oral presentation at the 35th Congress of The European Committee for Treatment and Research in Multiple Sclerosis

Innovative Medicine

September 9, 2019

New Data from Esketamine Nasal Spray Phase 3 Studies Showed Rapid Reduction of Depressive Symptoms in Adult Patients with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent

Global clinical program is the first to study this severely ill patient population, who are typically excluded from antidepressant treatment studies

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