FDA Approves Expanded Label for AZILECT® for Treatment Across All Stages of Parkinson’s Disease
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for AZILECT® (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). The new indication reflects that AZILECT® can be used alone or in combination with other Parkinson’s disease (PD) medications. The approval reinforces the growing clinical evidence demonstrating the benefit of AZILECT® across all stages of PD.
“The FDA approval of the expanded label for AZILECT® will be a welcome addition in the treatment of PD,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs.”
The FDA approval of the expanded label is based on a supplemental new drug application (sNDA) submitted by Teva, supported by data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease).The study demonstrated AZILECT® provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.
“AZILECT® has been well studied and has been shown to be safe and effective as monotherapy in early PD and as an adjunct to LD in moderate-to-advanced PD. The ANDANTE study provides evidence that AZILECT® is also effective as an adjunct to dopamine agonist therapy,” said Robert A. Hauser, M.D., MBA, Professor of Neurology, Molecular Pharmacology, and Physiology at the University of South Florida. “The expanded AZILECT® indication supports the concept of adding AZILECT® to DA monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of DA monotherapy or initiating LD.”
AZILECT® (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).
IMPORTANT SAFETY INFORMATION
Do not take AZILECT if you are taking meperidine as it could result in a serious reaction such as coma or death. Also, do not take AZILECT with tramadol, methadone, propoxyphene, dextromethorphan, St. John’s wort, or cyclobenzaprine. You also should not take AZILECT with other monoamine oxidase inhibitors (MAOIs), as it could result in an unsafe rise in blood pressure.
Increases in blood pressure may occur during treatment with AZILECT. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, difficulty thinking, seizure, chest pain, and nausea/vomiting. It is important that if you experience these symptoms that you speak with your doctor or seek medical attention. When AZILECT is taken at recommended doses, restriction of foods and beverages containing a substance called tyramine is ordinarily not required. However, it is recommended that you avoid foods containing high amounts of tyramine such as aged cheeses as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure as described above.
Inform your physician if you are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and ciprofloxacin. The combination of MAO-B inhibitors such as AZILECT and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome.
If you experience episodes of falling asleep or drowsiness during activities of daily living, do not drive and exercise caution until you contact your physician.
If you have moderate to severe liver disease, you should not take AZILECT. You should not exceed a dose of 0.5 mg per day of AZILECT if you have mild liver disease or are taking ciprofloxacin. Patients should not exceed a dose of 1 mg per day of AZILECT because of the risk of increased blood pressure.
All PD patients should be monitored for a change in blood pressure, uncontrolled movements (dyskinesia), hallucinations, impulse control, confusion, and melanoma (skin cancer). A possible rise in body temperature may occur upon stopping AZILECT.
The most common side effects seen with AZILECT alone are flu syndrome, joint pain, depression, and indigestion; when taken with a dopamine agonist are swelling of the legs, fall, joint pain, cough, and inability to sleep; and when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and swelling of tendons.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full prescribing information at www.azilect.com/Resources/pdf/PrescribingInformation.pdf
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
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