Janssen’s Zytiga (Abiraterone Acetate) Added to WHO Essential Medicines List for Metastatic Castration-Resistant Prostate Cancer

July 22, 2019/BioonBIOON/-- Janssen Pharmaceuticals, a subsidiary of US pharmaceutical giant Johnson & Johnson (JNJ), recently announced that the World Health Organization (WHO) has included Zytiga (abiraterone acetate) in its Model List of Essential Medicines for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The World Health Organization’s Model List of Essential Medicines is a core guidance document that helps countries prioritize key, affordable medical products recommended for widespread availability throughout the health system. Established in 1977, the list serves as a standard template for governments to select medicines that address local public health needs and to develop national essential medicines lists. Since its inception, the model list has proven to be a powerful tool for promoting primary health care by rationalizing the selection and use of medicines, as well as their pricing.

Janssen Europe, Middle East and Africa (EMEA) Therapeutic AreaTumorDr. Joaquín Casariego, the academic lead, stated, “The inclusion of Zytiga in the WHO Model List of Essential Medicines underscores the pivotal role this drug plays in improving the lives of patients with metastatic castration-resistant prostate cancer (mCRPC) and their families. I am proud that we are striving to impact patient survival and quality of life by developing and providing innovative medicines supported by the highest-quality scientific evidence.”

Biljana Naumovic, Vice President of Oncology Commercial Strategy for Janssen EMEA, stated: “Adding Zytiga to the Essential Medicines List is a testament to Janssen’sTumora significant milestone in learning, reflecting the tireless efforts in recent years to bring optimal treatment options to patients with metastatic castration-resistant prostate cancer (mCRPC). This direction from the World Health Organization further emphasizes that our work is not yet complete. It is crucial that prostate cancer patients have access to treatments deemed beneficial by their clinicians. We will continue to support the prostate cancer community, with the shared goal of making this cancer a controllable disease and, potentially one day, a curable one.”

Zytiga is an oral medication that is converted in the body to abiraterone, an inhibitor of androgen biosynthesis, in the testes, adrenal glands, and prostate.TumorInhibition of CYP17-mediated androgen production in tissues, as androgens can stimulate the growth of prostate cancer cells.

Since its initial approval in 2011, this drug has been approved in more than 100 countries worldwide for use in combination with prednisone/prednisolone: (1) in combination with androgen deprivation therapy (ADT) for the treatment of newDiagnosis(1) adult males with high-risk metastatic hormone-sensitive prostate cancer (mHSPC); (2) adult males with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who have failed androgen deprivation therapy (ADT) and have no clinical indication for chemotherapy; (3) adult males with mCRPC whose disease has progressed during or after docetaxel-based chemotherapy.

Zytiga is a blockbuster drug from Johnson & Johnson, with global sales reaching $3.5 billion in 2018. Notably, last October, the U.S. District Court for the District of New Jersey ruled that Zytiga’s U.S. Patent No. US8822438 was invalid; this patent was originally set to expire in 2027. Currently, patent litigation concerning Zytiga is ongoing in the U.S. market. If the patent is ultimately declared invalid, Zytiga will face intense competition from generic drugs. (Bioon.com)

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