Breaking News
March 25, 2019 - Inherited form of rickets improves more with new injectable medicine than conventional therapy
March 25, 2019 - Trastuzumab Tied to Higher Long-Term Risk for Heart Failure
March 25, 2019 - Personal context directly affects CPAP use
March 25, 2019 - Mosquito tracking key to preventing disease outbreaks
March 25, 2019 - Scientists Detect Hidden Signals from Beneficial Bacteria
March 25, 2019 - Treating women with thyroid antibodies with Levothyroxine do not increase live birth rate
March 25, 2019 - Brain area that only processes spoken, not written words identified
March 25, 2019 - Race and ethnicity influence fracture risk in diabetic patients
March 25, 2019 - Researchers report new regenerative medicine approach for treating osteoarthritis of the knee
March 25, 2019 - Exposure to dim light at night may contribute to spread of breast cancer to bones
March 25, 2019 - Benefits of osteoporosis treatment in postmenopausal women outweigh the perceived risks
March 25, 2019 - Researchers find evidence of Cryptosporidium parasite in Minnesota’s public water systems
March 25, 2019 - Three Clues to Raised Risk of Miscarriage
March 25, 2019 - Structured play helps toddlers self-regulate, altering their life course
March 25, 2019 - Translating horror into justice: Stanford psychiatrist advocates for human rights
March 25, 2019 - HORIBA Medical introduces D-Dimer reagent for Yumizen G hemostasis range
March 25, 2019 - Recurrent pregnancy loss may be caused by sperm DNA damage, finds study
March 25, 2019 - Special Collection tracks development of new diagnostic tests for tuberculosis
March 25, 2019 - Air Force develops genetic test to predict mental performance
March 25, 2019 - To abort or not to abort—making difficult choices alone
March 25, 2019 - Computer vision technology could aid ICU care by spotting movement
March 25, 2019 - IONTAS wins ‘Small Business of the Year’ category at Cambridge News Business Excellence Awards 2019
March 25, 2019 - First postpartum depression drug gets FDA nod
March 25, 2019 - Research Recognition Award will help improve lives of young people with absence epilepsy
March 25, 2019 - Bisphosphonates to treat osteoporosis appears to be beneficial for all women
March 25, 2019 - Researchers develop new augmented reality app to assess spatial memory
March 25, 2019 - Dolomite Bio releases new Drop-seq datasets for single-cell RNA sequencing
March 25, 2019 - Hemoglobin A1c blood test may underestimate prevalence of diabetes
March 25, 2019 - Immune system errors linked to development of childhood leukemia
March 25, 2019 - Eating leafy green vegetables may help maintain muscle strength and mobility
March 25, 2019 - BMA secures state-backed clinical negligence indemnity scheme for GP trainees
March 25, 2019 - Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant
March 25, 2019 - Adding breakfast to classrooms may have a health downside
March 25, 2019 - She Was Dancing On The Roof And Talking Gibberish. A Special Kind Of ER Helped Her.
March 25, 2019 - KNAUER introduces new Sepapure FPLC columns and media for protein purification tasks
March 25, 2019 - Weight loss in obese migraine sufferers can improve their quality of life
March 25, 2019 - Exposure to particulate air pollution may lead to reduced sperm production
March 25, 2019 - Synthetic peptide appears to disrupt inflammation and protect kidneys from nephritis
March 25, 2019 - New guideline focuses on strategies to improve health of older adults with diabetes
March 25, 2019 - Study evaluates prescribing of preventive drugs at the end of life in older adults with cancer
March 25, 2019 - Radial or femoral approaches for PCI are equal in terms of survival in heart attack patients
March 25, 2019 - Study shows how some autoimmune diseases are more closely related than others
March 25, 2019 - Long term opioid medications impacts production of important hormones
March 25, 2019 - FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
March 25, 2019 - CDC researchers report on trends in hospital breastfeeding policies
March 25, 2019 - States Push For Caregiver Tax Credits
March 25, 2019 - Females on ketogenic diet fail to show metabolic benefits in animal model
March 25, 2019 - Modulating stiffness of blood-forming stem cells could facilitate mobilization procedures
March 25, 2019 - Gene editing regulations to be tightened
March 25, 2019 - CPAP treatment can result in weight loss in people with sleep apnea and obseity
March 25, 2019 - Highly attractive businesswomen are considered less trustworthy ‘femmes fatales’
March 25, 2019 - Breast Density Categorization Varies With Screening Modality
March 25, 2019 - Researchers explore link between metal exposure and Parkinson’s symptoms
March 25, 2019 - Later meal timing may contribute to weight gain
March 25, 2019 - Around one in hundred people has autism spectrum condition in China
March 25, 2019 - Research paves way for new standard of care to improve heart’s pump function
March 25, 2019 - Exposure to HIV virus, antiretroviral therapy before birth linked to obesity and asthma-like symptoms
March 25, 2019 - Transgender men preserve their fertility potential after one year of testosterone therapy
March 25, 2019 - Tighter Blood Pressure Control May Prevent Brain Lesions
March 25, 2019 - A reward now or later? Exploring impulsivity in Parkinson’s disease patients
March 25, 2019 - Financial incentives fail to increase completion rates of colorectal cancer screening tests mailed to patients
March 25, 2019 - New research program launched to highlight sexual harassment in academia
March 25, 2019 - Hemoglobin A1c blood test does not detect diabetes in most patients, shows study
March 25, 2019 - Wyss Technology licensed by Sherlock Biosciences to create affordable molecular diagnostics
March 25, 2019 - DWK Life Sciences launches KIMBLE GLS 80 Media Bottle and Multiport Cap System
March 25, 2019 - New study aims to reduce online sexual exploitation of children
March 25, 2019 - Want healthier eating habits? Start with a workout
March 25, 2019 - New approach to prescribing antibiotics could curb resistance
March 24, 2019 - Theravance Biopharma Announces First Patient Dosed in Phase 2b/3 Study of TD-1473 in Patients with Ulcerative Colitis
March 24, 2019 - Prenatal DHA prevents blood-pressure increase from obesity during childhood
March 24, 2019 - Combined immunosuppression may be effective, safe in treating older patients with Crohn’s disease
March 24, 2019 - GSK sells health drinks arm, buys US cancer treatment firm
March 24, 2019 - Bacteria and innate immune factors in birth canal, cervix may be key to predicting preterm births
March 24, 2019 - IgG antibodies play unexpected role in atherosclerosis
March 24, 2019 - Sounds and vibrations are quite similar for the brain, finds new study
March 24, 2019 - Practices for Reducing COPD Hospital Readmissions Explored
March 24, 2019 - Could an eye doctor diagnose Alzheimer’s before you have symptoms?
March 24, 2019 - Enzyme inhibitor stops inflammation and neurodevelopmental disorders in mouse models
March 24, 2019 - Walk, Dance, Clean: Even a Little Activity Helps You Live Longer
March 24, 2019 - Americans used less eye care in 2014 versus 2008
Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

image_pdfDownload PDFimage_print

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

MUMBAI & PRINCETON, N.J. & KING OF PRUSSIA, Pa. May 23, 2018 –(BUSINESS WIRE)–Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration (FDA) for Yonsa (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO – North America, Sun Pharma.

Yonsa in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.

About Yonsa (abiraterone acetate) tablets

Yonsa is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology™ to create a micronized (smaller particle size) formulation of abiraterone acetate tablets – for the treatment of metastatic castration-resistant prostate cancer, in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis.

INDICATION

Yonsa (abiraterone acetate) in combination with methylprednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Important Administration Instructions

To avoid substitution errors and overdose, be aware that Yonsa tablets may have different dosing and food effects than other abiraterone acetate products. Patients receiving Yonsa should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Yonsa can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Hypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess: Yonsa may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with Yonsa.

Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. The safety of Yonsa in patients with left ventricular ejection fraction

Adrenocortical Insufficiency (AI): AI was reported in patients receiving abiraterone acetate in combination with corticosteroid, following an interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of AI, particularly if patients are withdrawn from corticosteroids, have corticosteroid dose reductions, or experience unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with Yonsa. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity: In postmarketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with Yonsa, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced Yonsa dose of 125 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt Yonsa treatment and closely monitor liver function.

Re-treatment with Yonsa at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

Permanently discontinue treatment with abiraterone acetate for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

The safety of Yonsa re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

ADVERSE REACTIONS

The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

DRUG INTERACTIONS

Based on in vitro data, Yonsa is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during Yonsa treatment. If a strong CYP3A4 inducer must be co-administered, increase the Yonsa dosing frequency only during the co-administration period.

Abiraterone is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8.

Avoid coadministration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug.

In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with an abiraterone acetate single dose equivalent to Yonsa 500 mg. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with abiraterone acetate.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception.
Do not use Yonsa in patients with baseline severe hepatic impairment (Child-Pugh Class C).
Please see Full Prescribing Information for Yonsa at www.YonsaRx.com/Yonsa-pi

Disclaimer:

Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

About Sun Pharmaceutical Industries Inc., USA (SPII)

SPII is a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd, a global specialty generic company based in Mumbai, which provides innovative, high-quality, affordable medicines trusted by customers and patients in over 150 countries around the world. It fosters excellence through innovation, supported by strong R&D capabilities, with approximately 2,000 scientists on staff and R&D investments of approximately 8% of annual revenues. It has been marketing its products in the US market for more than 20 years, providing generics, branded generics and over-the-counter products, and has distribution and customer service teams throughout the US. For further information please visit www.sunpharma.com and follow us on Twitter at @SunPharma_Live

The corporate footprint of SPII is rapidly growing, with a newly established branded, specialty business headquartered in Princeton, NJ. The company is expanding its portfolio of products and technologies that offer unique formulations and novel delivery systems of common therapies, across various disease areas.

This newly formed branded specialty business is also growing its oncology division, as evidenced by its portfolio of oncology products, including YONSA® (abiraterone acetate) – which is manufactured in the U.S – and Odomzo® (sonidegib). SPII is committed to enhancing patient access to innovative cancer therapies.

About Churchill Pharmaceuticals, LLC

Churchill is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Our commitment to responsibly deliver these products to the patients, payers and healthcare communities we serve is at the core of our business. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology™, a proprietary manufacturing process that may unlock the potential of certain oral drugs by changing how well they dissolve and how efficiently they are absorbed. For more information, please visit https://www.churchillpharma.com and http://www.iceutica.com

Source: Sun Pharmaceutical Industries Ltd.

Posted: May 2018

Related Articles:

Yonsa (abiraterone acetate) FDA Approval History

Tagged with:

About author

Related Articles