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September 30, 2020

Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)

August 3, 2020

Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior

· SPRAVATO® is the first and only approved antidepressant medication shown to begin improving depressive symptoms with the first dose in this challenging to treat patient population · Approval is based on Phase 3 data showing SPRAVATO® reduced depressive symptoms in as little as four hours in some patients, with symptom improvement maintained through the four-week treatment period

Innovative Medicine

July 17, 2020

Interim Six-Month Data of RPGR Gene Therapy Shows Significant Vision Improvement in Patients Living with X-Linked Retinitis Pigmentosa

First data to read out from the Janssen and MeiraGTx collaboration Johnson & Johnson to review interim Phase 1/2 clinical trial findings in pre-recorded webcast Company anticipates progressing the program to Phase 3

Innovative Medicine

July 14, 2020

TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

In two Phase 3 clinical trials, TREMFYA significantly improved signs and symptoms in joints, skin and soft tissue in adults with active psoriatic arthritis TREMFYA is the first and only biologic approved for the treatment of active psoriatic arthritis to have improvement in fatigue as measured by FACIT-F in the product label More than 45,000 patients in the U.S. with moderate to severe plaque psoriasis have been treated with TREMFYA since its original approval in 2017

Global health equity

July 6, 2020

Stop TB Partnership and Johnson & Johnson, with support from USAID and The Global Fund, Announce Price Reduction for SIRTURO® (bedaquiline) for Treatment of Drug-Resistant Tuberculosis in Low- and Middle-Income Countries

Joint efforts aim to accelerate scale-up of WHO-recommended all-oral treatment regimens – a transition urgently needed to help protect the health of people with drug resistant-tuberculosis who are particularly vulnerable during COVID-19 pandemic In 2020, the initiative aims to reach at least 125,000 patients and could save National TB Programs in low- and middle-income countries up to USD$16 million

Global health equity

July 1, 2020

Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine

This marks the first major regulatory approval of a vaccine developed by Janssen The Ebola vaccine regimen leverages Janssen’s AdVac® technology, plus Bavarian Nordic’s established MVA-BN® technology Janssen’s AdVac® technology is also being used to develop a vaccine candidate to prevent COVID-19

Innovative Medicine

June 26, 2020

Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus

Innovative Medicine

June 15, 2020

Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

Phase 3 ANDROMEDA study investigated the first and only subcutaneous anti-CD38 monoclonal antibody in treatment of rare multi-system disease with a high unmet medical need andfor which there are currently no approved therapies Data selected as late-breaking abstract and featured in press briefing at European Hematology Association (EHA) Annual Congress

Global health equity

May 29, 2020

Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen

The investigational Ebola vaccine regimen leverages Janssen’s established AdVac® and PER.C6® technologies and Bavarian Nordic’s MVA-BN® technology The AdVac® and PER.C6® technologies have been used to construct Janssen’s COVID-19, Zika, Respiratory Syncytial Virus (RSV) and HIV vaccine candidates

Global health equity

May 27, 2020

U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis

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