Janssen Submits Additional Marketing Applications for ZYTIGA® in the European Union and in the U.S.

2012-06-15 14:03:08

Beerse, Belgium And Raritan, New Jersey (ots/PRNewswire) - ?

Simultaneous Submissions Based on Data from Pre-chemo Prostate Cancer Study

Janssen-Cilag International NV announced today it has submitted a type II variation to the European Medicines Agency (EMA) for ZYTIGA(R); simultaneously, Janssen Research & Development, LLC submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA); Both applications are intended to extend the use of ZYTIGA administered with prednisone for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.

Both regulatory applications follow the announcement [http://www nts-in-asymptomatic-or-mildly-symptomatic-chemotherapy-naive-patients -with-metastatic-castration-resistant-prostate-cancer-156570325.html ] of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study. This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of ZYTIGA plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this month.

"We're delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago," said Michael L. Meyers, M.D., Ph.D., Vice President, Compound Development Team Leader, ZYTIGA. "We look forward to working with the FDA and EMA to make ZYTIGA available for men with metastatic prostate cancer earlier in the course of their disease."

The company previously announced the study was unblinded based on the unanimous recommendation of an Independent Data Monitoring Committee (IDMC). Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA.

"As a company, we strive to develop innovative therapeutic options that meet the unmet needs of patients suffering from devastating diseases such as mCRPC," said William N. Hait, M.D., Ph.D., Global Head, Janssen Research & Development and Head, Oncology Therapeutic Area. "These regulatory submissions for ZYTIGA are a clear example of our efforts to bring extraordinary oncologic therapies to those with the greatest need."


ZYTIGA in combination with prednisone was approved by the U.S. Food and Drug Administration (FDA) in April 2011 and by the European Commission in September 2011 for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel.

About Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world. More information can be found at

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism.

Important Safety Information

Contraindications - ZYTIGA(R) (abiraterone acetate) is not for use in women. Abiraterone acetate is contraindicated in women who are or may potentially be pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia, and fluid retention. ZYTIGA(R) may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure because these patients were excluded from the randomised clinical trial. Control hypertension and correct hypokalemia before and during treatment.

Monitor blood pressure, serum potassium, and symptoms of fluid retention before treatment and at least monthly thereafter.

Adrenocortical Insufficiency (AI) - AI has been reported in clinical trials in patients receiving ZYTIGA(R) in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA(R). Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity - Increases in liver enzymes have led to interruption, dose modification, and/or discontinuation of ZYTIGA(R). Monitor liver function and modify, withhold, or discontinue ZYTIGA(R) dosing as recommended (see Prescribing Information for further details). Measure serum transaminases prior to starting treatment with ZYTIGA(R), every two weeks for the first three months of treatment, and monthly thereafter. If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases, in particular serum ALT, should be measured immediately. If at any time the ALT rises above 5 times the upper limit of normal, treatment should be interrupted immediately and liver function closely monitored. Re-treatment may take place only after return of liver function tests to the patient's baseline and at a reduced dose level. If patients develop severe hepatotoxicity (ALT 20 times the upper limit of normal) anytime while on therapy, treatment should be discontinued and patients should not be re-treated.

The safety of ZYTIGA(R) in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA(R).

Food Effect - ZYTIGA(R) must be taken on an empty stomach. Exposure to abiraterone increases up to 10-fold when ZYTIGA(R) is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA(R) is taken and for at least one hour after the dose of ZYTIGA(R) is taken. Abiraterone Cmax and AUC0-lemniscate(exposure) were increased up to 17- and 10-fold, respectively, when a single dose of ZYTIGA(R) was administered with a meal compared to a fasted state.

Adverse Reactions - The most common adverse reactions (greater than or equal to 1/10) are hypokalemia, peripheral oedema, urinary tract infection and hypertension.

Drug Interactions - ZYTIGA(R) is an inhibitor of the hepatic drug-metabolising enzyme CYP2D6. Caution is advised when ZYTIGA(R) is administered with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index. Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered. Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecanide, codeine, oxycodone and tramadol (the latter three products requiring CYP2D6 to form their active analgesic metabolites).

Based on in vitro data, ZYTIGA(R) is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) should be avoided, or used with caution during treatment with ZYTIGA(R).


Media Inquiries Europe, Middle-East and Africa: Brigitte Byl,
+32-14-60-71-72. Satu Glawe, +49-2638-94-99-63. Media Inquiries
Kellie McLaughlin, Janssen Global Services, LLC, +1-908-927-7477
+1-609-468-8356 cell. Lisa Vaga, Janssen Biotech, Inc.,
office, +1-908-670-0363 cell. .Investor Relations: Stan Panasewicz,
+1-732-524-2524 office. Louise Mehrotra, +1-732-524-6491 office


Janssen Pharmaceutica

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