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 :

» Research Vital Statistics and Information On Virtually Any Medicine

is a useful database of information about the prescription and over-the-counter medication, allowing you to look up the possible side effects of specific drugs and see statistics about their reported problems.If you were to look up the allergy...

» Researchers Testing Intense Pulsed Light As An Alternative Treatment for Telangiectatases

Telangiectatases are knot-like clusters of blood vessels on the skin which can occur in 30 to 50 per cent of patients with Systemic Sclerosis, also known as . Telangiectases tend to occur on the face, neck, and upper limbs and can cause...

» arGentis Issued Key Patent Related to Treating Fibrosing Diseases by Induction of Immune Tolerance

arGentis Pharmaceuticals, LLC today announced the issuance of United States patent 7,718,765, entitled “Methods for Treating Fibrosing Diseases by Induction of Immune Tolerance." The issued patent, based on the seminal research of Arnold E....

» Italians Explain Low Sex Drive In Female Scleroderma Patients

In a world first, Italian rheumatologists have discovered why women living with Systemic Sclerosis often suffer from a low sex drive. The study of 22 women with systemic sclerosis found the disease resulted in a lack of blood flow around the...

» Autoimmune Diseases May Increase Cancer Risk

A new study reveals that patients with certain autoimmune diseases are more likely to develop cancer. The new information could help doctors diagnose cancer at a much earlier stage.Two years ago, 67- year- old Dorothy Adams noticed a thickening and...

» Restoring Alkalinity in the Body

All foods are "burned" within the body, leaving an ash as the result of the "burning" or digestion. This food ash can be neutral, acid or alkaline, depending largely on the mineral composition of the foods.Some foods leave an acid residue or ash,...