The AP (5/26) reports that the Food and Drug Administration "approved Genzyme's drug to treat a muscle development disease." The drug, called Lumizyme (alglucosidase alfa), has just been approved to treat patients with Pompe disease in the United States and is currently manufactured in Belgium, where it is known as Myozyme.
The Boston Globe (5/26, Weisman) reports, "The decision represents the most important US drug approval for the Cambridge biotechnology company since 2003, when regulators signed off on Fabrazyme [agalsidase beta], a treatment for Fabry disease. Genzyme hopes Lumizyme will become a blockbuster, with worldwide sales of at least $1 billion annually."
The Boston Herald (5/26, McConville) reports, "The Cambridge biotechnology company said the drug will be sold in a box that warns users of potentially life-threatening anaphylactic reactions, severe allergic reactions and immune-mediated reactions." According to the company, it "will only give the drug to patients who are eight or older and enrolled in a risk mitigation program."
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