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March 26, 2021

Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features

Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis[1] The OPTIMUM study demonstrated a statistically significant reduction in relapses and number of inflammatory lesions compared with teriflunomide[2]

Innovative Medicine

March 19, 2021

Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions

Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator Approval follows more than 10 years of cumulative data demonstrating the treatment’s efficacy and safety

Innovative Medicine

March 16, 2021

New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years

Data show more than 50 percent of adults with active PsA achieved complete skin clearance (PASI 100) and more than 70 percent achieved at least 20 percent improvement in joint symptoms (ACR 20) These data mark the first and only long-term Phase 3 study results for a selective interleukin (IL)-23 inhibitor therapy in PsA, which include impact on radiographic progression through two years

Innovative Medicine

February 24, 2021

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months

If approved, expanded use would offer adults living with HIV an every-two-months long-acting injectable option for maintaining viral suppression

Innovative Medicine

February 8, 2021

Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer

Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease

Innovative Medicine

February 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination

ACIS study meets primary endpoint of improving time to radiographic progression or death in patients with advanced disease

Innovative Medicine

February 8, 2021

SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder

· This milestone makes esketamine nasal spray the first N-methyl-D-aspartate (NMDA) antagonist to be approved for patients with Major Depressive Disorder (MDD) in a psychiatric emergency1–3 · European Commission (EC) authorisation is based on results from two Phase 3 ASPIRE studies, which evaluated the efficacy and safety of esketamine nasal spray used in addition to comprehensive standard of care (SOC)4–6 · This authorisation marks the second indication for esketamine nasal spray in the European Economic Area (EEA)7

Innovative Medicine

February 4, 2021

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021

Innovative Medicine

January 21, 2021

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression

Innovative Medicine

December 21, 2020

Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma

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