The U.S. Food and Drug Administration said Tuesday that it has approved Genzyme Corp.’s (GENZ) Lumizyme, a treatment for the rare genetic disorder Pompe disease. Genzyme shares rose more than 5 percent and as high as $51.90 on the news.
“This is an important day for the Pompe community, especially for those patients with late-onset Pompe disease in the United States who are awaiting treatment for this devastating disease,” said in a statement Genzyme Chairman and Chief Executive Officer, Henri A. Termeer. “We are grateful to the FDA for their efforts to approve Lumizyme ahead of its scheduled PDUFA date.”.
Genzyme’s FDA approval comes as the co. braces for a proxy battle led by billionaire investor Carl Icahn, who is seeking representation for himself and three others on the company’s board.