Innovative Medicine

Phase 3 VOYAGER PAD is the first investigational study in 20 years to highlight the benefit of long-term treatment in these high-risk patients Data add to growing body of evidence on the role of dual pathway inhibition in targeting both thrombin generation and platelets

Up to 200,000 Johnson & Johnson Ebola vaccine regimens will be made available as part of a WHO early access clinical program now underway in Sierra Leone Company’s Ebola vaccine regimen also receives Prequalification from the WHO The Johnson & Johnson vaccine regimen is designed to be used proactively to induce immunity against Ebola in adults and children

Skin clearance rates were maintained at five years with 55.5 percent of patients achieving an Investigator’s Global Assessment score of 0 and 53 percent achieving Psoriasis Area Severity Index 100 response in VOYAGE 2 TREMFYA, the first and only selective interleukin (IL)-23 inhibitor therapy approved for both PsO and PsA, improved overall PsA disease activity as evaluated by composite disease activity scores, and PsA axial symptoms as evaluated by the Bath Ankylosing Spondylitis Disease Activity Index in DISCOVER-1 and -2

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