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TREMFYA®&9660;, Induces

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced Phase 2 interim data from the GALAXI 1 study, which showed TREMFYA®?

12.10.2020 - 09:02:43

TREMFYA®? Induces Clinical and Endoscopic Improvements in Patients with Moderately to Severely Active Crohn’s Disease based on Interim Results from Phase 2 Study

or search for MHRA Yellow Card in the Google Play or Apple App Store. AEs should also be reported to Janssen-Cilag Ltd on 01494 567447.

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-Cilag International NV, the marketing authorisation holder for TREMFYA® in the EU, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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 Phase 2 Week 12 interim study of TREMFYA® (guselkumab) in Crohn’s disease. 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 Research & Development, LLC, 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.

*Dr William J. Sandborn is a paid consultant for Janssen. He has not been compensated for any media work.

References

Sandborn, W, et al. The Efficacy and Safety of Guselkumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease: Week 12 Interim Analyses from the Phase 2 GALAXI 1 Study (Abstract OP089). Presented at the UEG Week Virtual 2020 Congress October 11–13.European Medicines Agency. TREMFYA Summary of Product Characteristics. 2019. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed October 2020.Clinicaltrials.gov. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03466411. Accessed October 2020.Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet 2017;390:2769-2778.Crohn’s and Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed October 2020.Crohn’s and Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed October 2020.Mayo Clinic. Crohn’s disease. Available at https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed October 2020.Benson JM, et al. Discovery and Mechanism of Ustekinumab. MAbs 2011;3:535.

 

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