River Vision Announces Receipt of Orphan Drug Designation
NEW YORK, June 11, 2013 /PRNewswire-iReach/ -- River Vision Development Corp. (River Vision) today announced that RV001, the Company's human monoclonal antibody teprotumumab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of active phase Graves Orbitopathy (GO), also known as Thyroid Eye Disease.
GO is a condition afflicting a proportion of Graves' Disease patients, in which an autoimmune response is mounted against tissues behind the eye, causing inflammation, tissue proliferation and excess production of extracellular matrix. The resulting excess tissue in the area behind the eye causes the eyeballs to protrude from the socket, often resulting in serious ocular morbidity and highly distressing changes in the patient's appearance.
Orphan Drug Designation is granted to drugs or biologics intended for treatment of rare diseases and disorders affecting fewer than 200,000 people in the U.S. This designation conveys special incentives to the sponsor, including tax credit for fifty percent of the cost of clinical trials, waiver of the prescription drug user fee, and seven years of U.S. market exclusivity for the drug or biologic upon FDA approval.
"The granting of River Vision's request for Orphan Drug Designation represents a significant milestone in the development of RV001 for GO," said Dave Madden, Chief Executive Officer of River Vision "and should prove helpful in our dialogue with the FDA as the compound's development progresses."
River Vision has commenced a Phase 2 clinical study in this indication and has begun to recruit patients at 8 sites around the country. Over the next several months, the number of sites will be expanded to a total of approximately 20. Patients interested in participating in the study can receive more information, including contact information for the sites, at ClinicalTrials.gov or GravesEyeDiseaseStudy.com.
About River Vision Development Corp.
River Vision Development Corp. was founded by Narrow River Management, LP (Narrow River) for the sole purpose of developing RV001 for GO and other potential indications. The Company is managed under contract with Narrow River, which funds and provides leadership expertise for special purpose drug development companies.
Media Contact: Dave Madden River Vision Development Corp., 212-582-8400 X105, firstname.lastname@example.org
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SOURCE River Vision Development Corp.
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