Protalex, a biopharmaceutical company dedicated to develop orphan drug or therapies for the effective treatment of patients with rare diseases, has recently announced that its novel drug candidate, PRTX 100 has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of persistent, chronic immune thrombocytopenia (ITP).
PRTX-100 is currently being evaluated in its Phase andfrac12; trial in patients who have previously been treated with a thrombopoietin receptor agonist and at least one additional ITP therapy. Each patient in the study will be given 4 weekly intravenous doses of PRTX-100 and is monitored for up to 48 weeks thereafter. PRTX-100 is a purified form of SpA, an immunomodulatory protein known to modify aspects of the human immune system. It is designed to bind to human B-lymphocytes and macrophages and to modulate immune processes.
FDA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such as incentives to the developing company. These benefits include market exclusivity for the marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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