MediGene Receives Authorization for the Clinical Formulation Study of RhuDex

01-Nov-2011 - Germany

MediGene AG announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted the authorization of the planned clinical formulation study of RhuDex®, a drug candidate being developed for the treatment of rheumatoid arthritis. The objective of the RapidFACTTM trial (Rapid Formulation Development and Clinical Testing) is to determine an optimized formulation for chronic treatment. Upon the initiation of the planned study, MediGene will provide additional details on the design and duration of the trial.

Dr. Frank Mathias, MediGene’s CEO, commented: “Preliminary formulations of RhuDex® permitted initial clinical trials of the drug candidate. For the long-term development and subsequent marketability of the product, however, we seek an improved formulation and dosage form of RhuDex® to facilitate a therapeutically ideal release of the active ingredient as well as patient-friendly dosing. We are delighted to be able to continue the clinical development of RhuDex® with an optimized product candidate.“

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