Navigation Links
FDA Grants Orphan Drug Status To Eisai's Lenvatinib
Date:2/14/2013

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65.

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 95 percent of all cases.  While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which is to help address unmet medical needs and to increase the benefits health care provides to patients and their families. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications.

Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Media InquiriesInvestor InquiriesLaurie Landau

Alex Scott Eisai Inc.

Eisai Inc.201-746-2510

201-746-2177


'/>"/>
SOURCE Eisai Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
2. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
3. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
4. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
5. FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
6. Rep. Fattah Announces More Than $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
8. Neuralstem Grants First Licenses For CNS Therapy Surgical Devices
9. EMA Grants Orphan Designation to Edison Pharmaceuticals for EPI-743 for Treatment of Leigh Syndrome
10. As Global Telemedicine Market Reaches $2.5 Billion, Industry Leaders Gather in San Diego to Discuss Grants, Funding, Vendor Selection, Credentialing, and More
11. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... WASHINGTON , May 9, 2017  Demonstrating ... the board of directors for the Pharmaceutical Research ... criteria for membership. Biopharmaceutical companies will now have ... in order to be eligible to join PhRMA. ... criteria, the board is sending a clear message ...
(Date:5/9/2017)... Ore. , May 9, 2017  Semler ... that provides technology solutions to improve the clinical ... financial results for the first quarter ended March ... our products enable our customers to identify when ... to intervene before events like heart attacks or ...
(Date:5/8/2017)... FLINT, Mich. , May 8, 2017  Diplomat ... WRB Communications, Inc. ("WRB"), a health care ... . WRB specializes in relationship management ... organizations. WRB will ... of Diplomat,s commercialization support services for manufacturers, biotech firms, ...
Breaking Medicine Technology:
(Date:5/23/2017)... ... May 23, 2017 , ... ... medical device sectors, today announced the winners of its 3rd Annual ELITE Awards. ... most influential people in the healthcare industry today. , Out of more than ...
(Date:5/23/2017)... ... 2017 , ... New England Journal Of Medicine Confirms Viability of Rory’s Regulations ... Rory Staunton Foundation Calls on Health & Human Services, Tom Price to Adopt Rory’s ... ) today reported on a new study released on May 21, 2017 in the ...
(Date:5/23/2017)... ... May 23, 2017 , ... The National Council on ... to announce the organization’s Certified Strength Coach credential has earned accreditation from the ... program validates the competency of qualified candidates for jobs in the Strength and ...
(Date:5/23/2017)... CA (PRWEB) , ... May 23, 2017 , ... ... Facial Plastic and Reconstructive Surgeon Dr. Kevin Sadati, is pleased to announce a ... in building collagen and elastin in their face, neck, and body through a ...
(Date:5/23/2017)... NV (PRWEB) , ... May 23, 2017 , ... ... Dental Specialists, are educating patients on peri-implantitis in Las Vegas, NV, ... to receive a custom gum disease consultation and leading care for peri-implantitis, with ...
Breaking Medicine News(10 mins):