Eisai Announces Filing for Marketing Authorization of BELVIQ® (lorcaserin HCI) for Chronic Weight Management in Brazil PR Newswire WOODCLIFF LAKE, N.J., Feb. 12, 2014 WOODCLIFF LAKE, N.J., Feb. 12, 2014 /PRNewswire/ --Eisai Inc. announced today that its subsidiary Eisai Laboratorios Ltda has filed for the marketing authorization of BELVIQ as a treatment for chronic weight management with the Brazilian Health Surveillance Agency (Anvisa). "In keeping with Eisai's human health care mission we are committed to providing access to innovative therapies to patients and physicians worldwide," said Frank Ciriello, Senior Vice President, Eisai Inc. "According to recent estimates, approximately 65 percent of the adult population in Brazil is overweight or obese, making this country an important priority for Eisai." BELVIQ is being submitted for marketing authorization in Brazil as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult obese patients (initial body mass index, or BMI, ≥ 30 kg/m^2), or overweight patients (initial BMI ≥ 27 kg/m^2) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular disease, type 2 diabetes managed with oral hypoglycemic agents, or sleep apnea). Under its agreement with Arena Pharmaceuticals, Eisai is responsible for seeking the regulatory approval and subsequent marketing and distribution of BELVIQ in Brazil. Arena has granted Eisai marketing and distribution rights to BELVIQ for all countries worldwide, except South Korea, Taiwan, Australia, New Zealand and Israel. About BELVIQ^® BELVIQ is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m^2 or greater (obese), or BMI of 27 kg/m^2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke. BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. Important Safety Information oPregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ may harm your unborn baby. oSerotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles. oValvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems. oChanges in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you. oMental problems: Taking too much BELVIQ may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body. oDepression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide. oLow blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops. oPainful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop taking BELVIQ and call your doctor or go to the nearest emergency room right away. oSlow heartbeat: BELVIQ may cause your heart to beat slower. oDecreases in blood cell count: BELVIQ may cause your red and white blood cell counts to decrease. oIncrease in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size. oMost common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation. oMost common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue. oNursing: BELVIQ should not be taken while breastfeeding. oDrug interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC) common cold/cough medicine); OTC supplements such as tryptophan or St. John's Wort; or erectile dysfunction medicines. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence. For more information about BELVIQ, click here for the full Product Information or visit www.BELVIQ.com. BELVIQ^® is a registered trademark of Arena Pharmaceuticals GmbH. About Eisai Inc. At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US. Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs. Media Inquiries Investor Inquiries Laurie Landau Alex Scott Eisai Inc. Eisai Inc. (201) 746-2510 (201) 746-2177 (Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO) SOURCE Eisai Inc. Website: http://www.eisai.com
Eisai Announces Filing for Marketing Authorization of BELVIQ® (lorcaserin HCI) for Chronic Weight Management in Brazil
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