Orphan Drug Status Granted For Revimmune In Treatment of Systemic Sclerosis PDF Print E-mail
Thursday, 23 June 2011 09:40
Accentia Biopharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RevimmuneTM, the company's proprietary system-of-care based on high-dose administration of Cytoxan(R) (cyclophosphamide), for the treatment of two autoimmune disease indications, systemic sclerosis and autoimmune hemolytic anemia. Based on a an exclusive world-wide license from Johns Hopkins University, Accentia intends to conduct multiple clinical trials evaluating Revimmune therapy for the treatment of a range of autoimmune diseases including multiple sclerosis.

With FDA Orphan Drug Status, Accentia gains seven years of market exclusivity for Revimmune for systemic sclerosis and autoimmune hemolytic anemia upon its approval by the FDA thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Accentia with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

Accentia's Chief Scientific Officer, Dr. Carlos Santos, Ph.D., commented, "There is an urgent unmet medical need for new treatments for systemic sclerosis and autoimmune hemolytic anemia, as nearly 100,000 patients in the U.S. alone are living with one of these highly debilitating and often deadly autoimmune diseases. Current treatment options, especially in severe cases, are limited with some patients left with no choice but to endure high-risk treatment approaches. However, preliminary open label studies conducted by physicians at Johns Hopkins University have shown that Revimmune therapy is capable of 'rebooting' the immune system by eliminating the circulating cells perpetuating the autoimmunity for patients suffering from either systemic sclerosis or autoimmune hemolytic anemia. Studies published by Johns Hopkins researchers have shown that the majority of those patients treated with Revimmune therapy achieved meaningful clinical benefit and in some cases even underwent complete remissions"

Source: MarketWatch (2011), "Accentia Biopharmaceuticals Announces that FDA grants Orphan Drug Status for Revimmune(TM) Therapy for the Treatment of Two Autoimmune Diseases: Systemic Sclerosis & Hemolytic Anemia"; original article can be found here.

 
More articles :

» March Designated as 'National Autoimmune Diseases Awareness Month' in the U.S.

On the evening of March 4, 2010, the U.S. Senate passed a resolution designating March as "National Autoimmune Diseases Awareness Month" and supporting efforts to increase awareness of autoimmune diseases and increase funding for autoimmune disease...

» The Interplay Between Environmental and Genetic Factors in Autoimmune Disorders

Autoimmune disorders constitute a group of more than 80 different diseases characterized by immune attack of components of a person’s own body, mediated by and autoreactive T cells. Specifically, the common feature that defines autoimmune...

» A Scleroderma Fact Sheet

Below, is a very useful fact sheet on Scleroderma. Making for much easier reading and reference, this fact sheet highlights what Scleroderma is, how is it diagnosed, who gets it, complications which may arise, and how it can be treated. Feel free to...

» Interferons As A Potential Treatment For Scleroderma

A variety of new treatments are being currently investigated and developed for the treatment of Systemic in hopes of better controlling symptoms and slowing the progression of the disease. Once such treatment is Interferons, in which recent studies...

» Leeds Study Could Help Treat Potentially Fatal Condition

A trial of special insoles is being masterminded by Leeds-based researchers to see if they can help sufferers of a potentially fatal tissue disorder. Patients with , a rare but serious connective disorder which leads to the thickening of body...

» Long Term Methotrexate Therapy Beneficial for Juvenile Localized Scleroderma

Researchers in Italy evaluated 65 patients with Juvenile Localized (JLS; or) previously enrolled in a double blind, randomized control trial and treated for the first 3 months with oral methotrexate (MTX; 15 mg/m2 weekly) and prednisone (1 mg/kg...