2019 Health for Humanity Report
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Mlolongo Blue Box Clinic, Kenya.

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R&D: Pharmaceutical

Our pharmaceutical R&D is focused in areas of medicine where we can make the most meaningful impact. These include: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We apply our expertise in small molecules, monoclonal antibodies, cell and gene therapies, RNA therapeutics and vaccines. We study biological pathways that underpin more than one disease to help speed development of new therapies for multiple conditions. We harness cutting-edge analytical tools to analyze sources of data to help us better identify targets, improve the probability of success in advancing promising candidates, reduce research timelines, and evaluate our medicines more efficiently and effectively than ever before.

We progressed Pharmaceutical R&D on several fronts in 2019, in addition to those noted in our sections on Tackling the World's Toughest Health Challenges and Enhancing Access to Healthcare.

Our highly differentiated R&D strategy focuses on both disease areas and biological pathways, embraces evolving science and technology, drives data sciences into all aspects of discovering and developing transformational medicines, and reinforces our strong position as a partner and accelerator at the center of the biopharmaceutical ecosystem.
Mathai Mammen M.D., Ph.D., Global Head of R&D Janssen Pharmaceutical Companies of Johnson & Johnson
First new mechanism of action in decades to treat major depressive disorder
The U.S. Food and Drug Administration (FDA) and the European Commission both approved SPRAVATO (esketamine) CIII nasal spray, in conjunction with an oral antidepressant (specifically a SSRI or SNRI in the EU), to treat adults with treatment-resistant depression (TRD). The medicine is administered as a nasal spray that is absorbed by the lining of the nasal passages and into the blood stream. To support responsible use of the medication while ensuring patient access, SPRAVATO was launched with a controlled distribution model, including additional monitoring and comprehensive risk mitigation strategies. We have invested more than eight years in a comprehensive development program encompassing 28 clinical trials to bring SPRAVATO to the millions of adults who have been living with the burden of TRD for far too long.

A wide range of transformational medicine advances in 2019

  • New multiple myeloma medicine approval: The FDA approved DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd). This approval represents the first and only FDA-approved biologic therapy indicated for newly diagnosed patients who are eligible for a stem cell transplant.
  • Promise for patients with multiple myeloma: The FDA granted Breakthrough Therapy Designation for the BCMA CAR-T Therapy JNJ-4528. Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells, affecting tens of thousands of individuals.
  • New leukemia medicine approval: The FDA approved IMBRUVICA (ibrutinib) in combination with obinutuzumab in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults. This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL and marks the 10th FDA approval for IMBRUVICA since November 2013.
  • First-of-its-kind bladder cancer treatment: The FDA granted accelerated approval for BALVERSA (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma. BALVERSA is an important new therapy for a subset of patients with urothelial carcinoma who, up until now, had limited treatment options.
  • Advancing treatment for respiratory syncytial virus: The FDA granted Breakthrough Therapy Designation for our investigational vaccine for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in adults aged 60 years or older. Older adults are at risk of developing RSV, a highly contagious respiratory infection and a leading cause of bronchitis and pneumonia, affecting more than 64 million people each year worldwide.12
  • Promise for patients with prostate cancer: The FDA granted Breakthrough Therapy Designation for niraparib, an orally administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Niraparib is an investigational PARP inhibitor that we believe may help address an important unmet need for patients with mCRPC.
  • New diabetic kidney disease approval: The FDA approved INVOKANA (canagliflozin) to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes. The approval, which is based on the landmark Phase 3 CREDENCE renal outcomes study, makes INVOKANA the only medicine in nearly 20 years approved to slow the progression of DKD.
Highlight
Highlight
Janssen Research & Development announced a collaboration with the University of California, Berkeley and the University of California, San Francisco to expand data science research in healthcare. The program facilitated by Johnson & Johnson Innovation will recruit data scientists to research high-impact, data-science projects in healthcare with the goal of inspiring data-driven approaches to improve health and develop the next generation of leaders in healthcare data sciences.

Our Performance

Number of selected NME Pharmaceutical Pipeline – Recent Approvals/Potential Filings through 2023
(as of January 22, 2020)*
19
Number of new Janssen medicines approved by U.S. FDA over the past five years** 7
Number of U.S. FDA Breakthrough Therapy Designations received over the past five years** 7
*Filings/approvals assumed to be in the U.S. and EU through 2023 unless otherwise noted. This information is accurate as of the date hereof to the best of the Company’s knowledge. Refer to our Late Stage Pipeline for our Pharmaceutical business segment.
**U.S. FDA. “New Drug Therapy Approvals 2019.”

Notes: Number reflects NME approvals achieved by current Janssen Pharmaceutical Companies of Johnson & Johnson.

12 National Institute of Allergy and Infectious Diseases. Respiratory syncytial virus. Respiratory syncytial virus. Last accessed: September 2019.

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