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Janssen, Seeks

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO®? (esketamine) nasal spray.

15.01.2020 - 13:41:27

Janssen Seeks Expanded Use of SPRAVATO®? Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent. The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-to-severe depressive episode of major depressive disorder (MDD) who have current suicidal ideation with intent.

or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.

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.11,12 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.13,14 At its worst, MDD can be fatal, with MDD patients demonstrating a 20-fold higher risk of suicide than the rest of the population.15 Despite treatment advances, currently available antidepressant medications can take between four to six weeks to reach their full effect,16 and one-third of people who suffer from MDD do not respond to these treatments.17

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 the product development of SPRAVATO®?. 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 healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare 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 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q, and in 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. Neither 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.

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References

Canuso CM, et al. Presented at the 58th ACNP Annual Meeting, Orlando, Florida, US, 8–11 December, 2019: Poster 130.Fu DJ, et al. Presented at the 32nd ECNP Congress, Copenhagen, Denmark, 7–10 September, 2019: Poster P323.Ionescu DF, et al. Presented at the 32nd ECNP Congress, Copenhagen, Denmark, 7–10 September, 2019: Poster P607.Johnson & Johnson Ltd. Press release on October 2019. Available at: https://www.jnj.com/janssen-submits-supplemental-new-drug-application-to-u-s-fda-for-spravato-esketamine-ciii-nasal-spray-for-the-rapid-reduction-of-depressive-symptoms-in-adults-with-major-depressive-disorder-who-have-active-suicidal-ideation-with-intent (last accessed January 2020).Duman RS. F1000Research 2018;7:659.Johnson & Johnson Ltd. Press release on February 2019. Available at: https://www.jnj.com/fda-advisory-committee-recommends-approval-of-spravatotm-esketamine-nasal-spray-ciii-for-adults-with-treatment-resistant-depression (last accessed January 2020).European Medicines Agency. Esketamine nasal spray Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines (last accessed January 2020).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 2020).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 2020).Johnson & Johnson Press Release on August 2016. Available at: https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide (last accessed January 2020).World Health Organization (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 2020).World Health Organization (WHO). Depression. Available at: http://www.who.int/news-room/fact-sheets/detail/depression (last accessed January 2020).World Health Organization (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 2020).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.

Job code: EM-22939
Date of preparation: January 2020

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