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Old Tue Jun 26, 2007, 12:20 PM
Neil Cuadra Neil Cuadra is offline
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Join Date: Jul 2006
Location: Los Angeles, California
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Quote:
Originally Posted by Gordman View Post
Has it been tested so far?
Yes, it has been tested. That's necessary for FDA approval. According to the FDA announcement:
FDA based its approval on the company's randomized, double-blind, placebo-controlled clinical study of 87 patients with PNH and a series of other clinical studies. The controlled study showed that over a 26-week period half of the participants receiving Soliris had stabilization of blood hemoglobin concentrations compared with no stabilization among placebo-treated patients. Soliris-treated patients also required significantly fewer blood transfusions.
Drugs have risks as well as potential benefits, and physicians evaluate the tradeoffs for each patient. In the case of Soliris, for example, there is an increased risk of meningococcal infection, and it is recommended that patients receive meningococcal vaccinations. Minor side effects have also been reported in clinical studies, including headache, runny nose, back pain, and nausea.

PNH can be life threatening, and the availability of Soliris gives patients one more treatment option.

More information about the benefits and risks of Soliris is available from the manufacturer.
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