BELVIQ XR - a New Once-daily Formulation of BELVIQ for Chronic Weight Management Now Available in the United States

Oct 04, 2016 10:03 JST

Source: Eisai

TOKYO, Oct 04, 2016 - (JCN Newswire) - Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has launched BELVIQ XR 20mg tablets, a new once-daily formulation of BELVIQ (generic name: lorcaserin hydrochloride) for chronic weight management in the United States.

BELVIQ XR is an extended release formulation proven to be slowly absorbed in the body and to last throughout the day. The availability of once-daily BELVIQ XR (20mg) in a single tablet provides patients with another dosing option in addition to the conventional twice-daily BELVIQ (10mg).

Approval for twice-daily BELVIQ was obtained in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition from the U.S. Food and Drug Administration (FDA) in 2012 by Arena Pharmaceuticals, Inc., whom Eisai and Eisai Inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride, and was launched in June 2013. Once-daily BELVIQ XR was approved with the same indication by the FDA in July 2016.

"Eisai is committed to efforts in research and development, disease awareness as well as other activities in order to address the diverse needs of to those living with obesity - a chronic, progressive disease that has serious health consequences," said Paul Hawthorne, Senior Vice President, Americas Neurology Business Unit, Neurology Business Group, Eisai Inc. "We are excited to offer patients a once-daily option for chronic weight management that may help them achieve and sustain their weight loss goals."

Through the launch of BELVIQ XR, Eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.

About lorcaserin hydrochloride (U.S. brand name: BELVIQ, BELVIQ XR "lorcaserin")

Discovered and developed by Arena Pharmaceuticals, Inc., lorcaserin is a novel chemical entity that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. Lorcaserin was approved in June 2012 by the U.S. Food and Drug Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition, and was launched in the United States under the brand name BELVIQ in June 2013 after receiving a final scheduling designation from the U.S. Drug Enforcement Administration (DEA). In addition, the agreement granting Eisai exclusive rights to market and distribute lorcaserin in 21 countries throughout the Americas, was expanded in November 2013 to include most countries and territories worldwide, most notably the European Union, Japan and China (excluding South Korea, Taiwan, Australia, New Zealand and Israel).

Lorcaserin was approved in Mexico under the brand name VENESPRI in July 2016 with the same indication as for the United States. Furthermore, the agent is currently undergoing regulatory review in Brazil. Once-daily BELVIQ XR was approved with the same indication by the FDA in July 2016. The most common adverse reactions observed in multiple Phase III clinical studies on lorcaserin were headache, dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycemia, headache, back pain, cough and fatigue in patients with diabetes. For further information on lorcaserin in the United States, including Important Safety Information (ISI), please visit the BELVIQ product website (http://www.belviq.com).

About Worldwide Overweight and Obesity

In recent years, obesity has become a major global health problem, with more than 1.4 billion adults worldwide believed to be overweight and approximately 500 million of that number qualifying as obese. By region, around 170 million people in the United States and 150 million people in Europe are reported to fall into one or both categories, while in Asia, the overweight and obese population includes an estimated 100 million people in China and a further 25 million people in Japan. (Eisai's internal estimates)

Contact:

Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120

Source: Eisai
Sectors: BioTech

Related Press Release

Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)

April 18 2024 09:53 JST

Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan

April 17 2024 15:17 JST

French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics

April 03 2024 15:24 JST

Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA

April 01 2024 08:39 JST

Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical

March 29 2024 14:51 JST

Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture

March 29 2024 14:19 JST

Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024

March 29 2024 13:32 JST

Lifenet and Eisai Co-Develop Dementia Insurance "be"

March 21 2024 16:36 JST

Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace

March 21 2024 15:10 JST

Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients

March 06 2024 16:47 JST

More Press release >>

Latest Press Release

Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date
Apr 24, 2024 17:19 JST

MC and Denka Sign J/V Agreement in Fullerene Business
Apr 24, 2024 17:02 JST

Mitsubishi Motors Posts Record Sales in the Philippines in FY2023
Apr 24, 2024 13:56 JST

NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance
Apr 24, 2024 13:25 JST

Fujitsu SX Survey reveals key success factors for sustainability
Apr 23, 2024 10:25 JST

Fujitsu and METRON collaborate to drive ESG success: slashing energy costs, boosting productivity with new manufacturing industry solutions
Apr 22, 2024 16:09 JST

NEC Strengthens Commitment to Space Industry with Investment in Seraphim Space Venture Fund II
Apr 22, 2024 15:09 JST

Soft Space Launches the First and Only JCB Payment Gateway in Malaysia
Apr 22, 2024 15:00 JST

TOYOTA GAZOO Racing takes a one-two in Croatian thriller
Apr 22, 2024 10:47 JST

First-ever Mazda CX-80 Crossover SUV Unveiled in Europe
Apr 19, 2024 13:50 JST

Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces
Apr 19, 2024 10:17 JST

Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas
Apr 18, 2024 17:01 JST

Toyota Launches All-New Land Cruiser "250" Series in Japan
Apr 18, 2024 13:39 JST

Fujitsu and Oracle collaborate to deliver sovereign cloud and AI capabilities in Japan
Apr 18, 2024 11:14 JST

Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)
Apr 18, 2024 10:53 JST

All-New Triton Confirmed as First Double-Cab Pickup Truck to Achieve 2024 Five-Star ANCAP Safety Rating
Apr 18, 2024 09:22 JST

Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan
Apr 17, 2024 16:17 JST

Honda Unveils Next-generation EV Series for China
Apr 17, 2024 12:15 JST

Lexus presents Time at the 2024 Milan Design Week
Apr 16, 2024 18:49 JST

Mitsubishi Corporation Announces Participation in a DAC Project in Louisiana, USA
Apr 16, 2024 14:36 JST

More Latest Release >>