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Naglazyme Approved by Brazil's National Health Surveillance Agency
Date:2/3/2009

rity of individuals with MPS VI die from disease-related complications between childhood and early adulthood. Additional information can be found at www.mpsvi.com.

About Naglazyme

Naglazyme is the first and only enzyme replacement therapy indicated for the treatment of MPS VI. Naglazyme is indicated for patients with MPS VI. Naglazyme has been shown to improve walking and stair-climbing capacity.

The most common adverse events observed in clinical trials in Naglazyme-treated patients were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media. Severe reactions included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria. The most common symptoms of infusion reactions included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain were also reported. No patients discontinued for adverse events and all patients who completed the double-blind portion of the trial continued to receive weekly infusions of Naglazyme. Nearly all patients developed antibodies as a result of treatment, but the level of the immune response did not correlate with the severity of adverse events. Because antihistamine use may increase the risk of apneic episodes, evaluation of airway patency should be considered prior to the initiation of treatment. Consideration to delay Naglazyme infusion should be given when treating patients who present with an acute febrile or respiratory illness. Additional information can be found at www.naglazyme.com.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical co
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