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FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder

ilization of blood hemoglobin concentrations compared with no stabilization among placebo-treated patients. Soliris-treated patients also required significantly fewer blood transfusions.

Soliris' blockade of the body's natural immune system increases the patient's susceptibility to certain serious infections, particularly meningococcal infections that can cause bacterial meningitis, an infection of the tissue surrounding the spinal cord and brain. Serious meningococcal infection was the most important adverse reaction experienced by patients who received Soliris in clinical studies. Because of the high risk for serious meningococcal infections, all 196 PNH patients in the clinical studies were vaccinated with a meningococcal vaccine; two of them developed meningococcal sepsis (an infection of the bloodstream caused by meningococcal bacteria) during treatment with Soliris.

A special risk management plan for Soliris has been developed to address the risk of serious meningococcal infection. The labeling of the product contains a boxed warning and requires that patients receive meningococcal vaccination prior to receiving Soliris. The labeling also includes a Medication Guide for patients. In addition, the risk management plan includes an educational program for physicians.

Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product. About one person out of a million people will be diagnosed with PNH.

Source-Bio-Bio Technology
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