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Abiraterone Acetate Included in World Health Organisation's Essential Medicines List for the Treatment of Metastatic Castration-Resistant Prostate Cancer

BusinessWire - Fri Jul 19, 8:05AM CDT

The Janssen Pharmaceutical Companies of Johnson & Johnson is delighted with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA(R)) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.(1,2)

The WHO's Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.(1)

"The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families," said Dr. Joaquin Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which are supported by the highest quality scientific evidence."

The foundation of Janssen's scientific understanding in prostate cancer is based on the knowledge acquired through the development of innovative treatment options for mCRPC. Abiraterone acetate is an oral androgen biosynthesis inhibitor that is approved for the treatment of both mCRPC and metastatic hormone-sensitive prostate cancer, in Europe.(3,4)

"The addition of abiraterone acetate to the Essential Medicines List is a significant milestone for Janssen Oncology, reflecting the tireless efforts in recent years to bring optimal treatment options to patients with mCRPC," said Biljana Naumovic, Vice President Commercial Strategy Lead Oncology for Europe, Middle East & Africa, Cilag GmbH International. "This direction from the WHO further emphasises that our work is not yet over. It is critical that patients with prostate cancer have access to treatments that their clinicians feel can benefit them and that we continue to support the prostate cancer community in our common goal of making cancer a manageable and potentially one day, a curable condition."

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About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt 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 for our latest news. Janssen-Cilag S.A. and Cilag GmbH International are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

About abiraterone acetate (ZYTIGA(R))Abiraterone acetate plus prednisone/prednisolone is an approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer - the testes, adrenals and the tumour itself.(4,5,6)

Abiraterone acetate is an oral therapy, taken in combination with prednisone/prednisolone for the treatment of:(4)

newly diagnosed high risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicatedmCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen

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References

(1) World Health Organisation. WHO updates global guidance on medicines and diagnostic tests to address health challenges, prioritize highly effective therapeutics, and improve affordable access. Available at https://www.who.int/news-room/detail/09-07-2019-who-updates-global-guidance-on-medicines-and-diagnostic-tests-to-address-health-challenges-prioritize-highly-effective-therapeutics-and-improve-affordable-access. Last accessed July 2019.(2) World Health Organisation. World Health Organization Model List of Essential Medicines. Available at: https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?sequence=1&isAllowed=y. Last accessed July 2019.(3) Bedoya DJ and Mitsiades N (2012). Abiraterone acetate, a first-in-class CYP17 inhibitor, establishes a new treatment paradigm in castration-resistant prostate cancer. Expert Rev. Anticancer Ther. 12(1), 1-3. (4) European Medicines Agency. Zytiga Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf. Last accessed July 2019.(5) Hoy, SM. et al. Abiraterone Acetate: A review of its use in patients with metastatic castration-resistant prostate cancer drugs. Drugs 2013; 73:2077-2091.(6) Ritch, CR. Cookson, MS. Advances in the management of castration resistant prostate cancer. BMJ. 2016 Oct 17;355:i4405. Doi: 10.1136/bmj.i4405.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190719005230/en/

SOURCE: Janssen

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