Genentech OKd for New Use of Pulmozyme

Times Staff and Wire Reports

Genentech Inc. said the Food and Drug Administration approved use of its Pulmozyme for patients with the most severe form of cystic fibrosis. The drug, already approved for patients with less severe forms of the debilitating disease, helped improve lung functioning even in the most advanced patients, the company said. An FDA advisory panel recommended approval of the new use in October, though several panel members expressed concern that Genentech's clinical trials of Pulmozyme on severely ill patients failed to produce evidence of improvements in quality of life. Other panel members, though, said the measures of improved lung function demonstrated by Genentech's studies provide enough evidence that the drug should be approved for use in severely ill patients. Shares in South San Francisco-based Genentech fell 37.5 to close at $53.75 on the NYSE.

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