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SPRAVATO®&9660;, Esketamine

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of SPRAVATO®?

08.02.2021 - 09:02:27

SPRAVATO®? Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder

and to regulatory authorities.

For further safety information, please see the Summary of Product Characteristics available at https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf.

About Major Depressive Disorder

Major depressive disorder (MDD) affects nearly 40 million people of all ages in Europe and is one of the leading causes of disability worldwide.13,14 Individuals with depression, including MDD, experience continuous suffering from a serious, biologically-based disease, which has a significant negative impact on all aspects of life, including quality of life and function.15,16 At its worst, MDD can be fatal, with MDD patients demonstrating a 20-fold higher risk of suicide than the rest of the population.17 Despite treatment advances, currently available antidepressant medications can take between four to six weeks to reach their full effect, and one-third of people who suffer from MDD do not respond to these treatments.18,19

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/JanssenEMEA. Janssen Research & Development, LLC and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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Cautions Concerning Forward-Looking Statements.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding SPRAVATO® (esketamine nasal spray). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

# # #

References

Popova V, et al. Am J Psych 2019;176:428–438.Duman RS, et al. Nat Med 2016;22(3):238–249.Newport DJ, et al. Am J Psychiatry 2015;172(10):950–966.Fu DJ, et al. J Clin Psychiatry 2020;81(3):19m13191.Ionescu D, et al. Int J Neuropsychopharmacol 2020;pyaa068.Canuso C, et al. Presented at 58th Annual Meeting of Neuropsychopharmacology (ACNP); December 2019.European Medicines Agency. Esketamine nasal spray Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines (last accessed January 2021).Fedgchin M, et al. Intl J Neuropsychopharmacol 2019;22(10):616–630.Hillhouse TM & Porter JH. Exp Clin Psychopharmacol 2015;23(1):1–21.Johnson & Johnson Ltd. Press release on December 2019. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/spravatorv_esketamine_nasal_spray_approved_in_europe_for_adults_with_treatment-resistant_major_depressive_disorder.pdf (last accessed January 2021).Johnson & Johnson Ltd. Press release on March 2019. Available at: https://www.jnj.com/janssen-announces-u-s-fda-approval-of-spravatotm-esketamine-ciii-nasal-spray-for-adults-with-treatment-resistant-depression-trd-who-have-cycled-through-multiple-treatments-without-relief (last accessed January 2021).Johnson & Johnson Ltd. Press release on August 2020. Available at: https://www.jnj.com/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 (last accessed January 2021).World Health Organisation (WHO). Depression and Other Common Mental Health Disorders: Global Health Estimates, 2017. Available at: http://www.who.int/mental_health/management/depression/prevalence_global_health_estimates/en/ (last accessed January 2021).World Health Organisation (WHO). Depression. Available at: http://www.who.int/news-room/fact-sheets/detail/depression (last accessed January 2021).World Health Organisation (WHO). International Classification of Diseases 11th Revision (ICD-11). 6A71.3. 2019. Available at: https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f2139612744 (last accessed January 2021).American Psychological Association (APA). Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. 2013.Lepine JP, et al. Neuropsychiatric Dis Treat 2011;7(suppl 1):3–7.Machado-Vieira R, et al. Pharmaceuticals 2010;3(1):19–41.Ionescu D, et al. Dialogues Clin Neurosci 2015;17(2):111–126.

EM-40128
January 2021

@ businesswire.com