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Innovative Medicine

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease

Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature

Early-stage research suggests potential to prevent and treat all dengue serotypes With no treatments available, dengue infects up to 400 million people each year and the pace of outbreaks is increasing.[1] This research builds on Johnson & Johnson’s work to advance science against emerging and entrenched global public health threats

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine

Submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. Substantial increase in immune response when booster was given at six months The Company’s single-shot vaccine has demonstrated strong and long-lasting protection and durable immune responses in clinical studies

New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications

First examination of safety events in the 60 and over sub-population across STELARA indications, including inflammatory bowel disease where relatively little biologics safety data exists, are generally consistent with placebo Janssen presents 13 abstracts, including four oral presentations and two late breakers

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults

Positive Phase 2b data supporting further evaluation will be presented at IDWeek 2021

New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events

Pivotal UNIVERSE study published in the Journal of the American Heart Association Data included in recent New Drug Application submitted to FDA for two pediatric indications

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

Additional data show a booster increases protection 94 percent protection in the U.S. with booster given at two months Four-fold increase in antibodies when given at two months 12-fold increase in antibodies when booster given at six months

Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor

Oral presentation at ESMO Annual Congress 2021 – featured in a late-breaking abstract – reports efficacy and safety of BALVERSA® in combination with a PD-1 inhibitor in bladder cancer