Innovative Medicine

Data from the SPHERE Registry published in the Journal of Heart and Lung Transplantation

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]

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

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

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

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

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

· 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

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