Genentech Inc. of South San Francisco, Calif., announcedTuesday that the Food and Drug Administration granted orphandrug status to the company's recombinant human DNase totreat lung infections associated with cystic fibrosis.
Designed to encourage research into therapies for rare diseases,orphan drug status confers seven years exclusive marketingrights on drugs to treat medical conditions afflicting fewer than200,000 people.
Cystic fibrosis (CF) is the most common fatal genetic disease inthe United States, affecting about 30,000 children and youngadults. More than half of CF patients die before age 30 ofrespiratory failure caused by persistent lung infection.
DNase, the recombinant form of a naturally occurring enzyme,is intended to shorten the duration of each lung infection bydissolving the thick mucus that collects in the lungs. Results ofPhase 1 clinical trials for DNase, conducted at the NationalInstitutes of Health and the University of Washington, areexpected to be released during the first half of this year, saidGenentech spokesman Jack Murphy. -- Rachel Nowak
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