Less than two months after an FDA advisory panel recommendedextending use of Genentech Inc.'s Pulmozyme to cystic fibrosispatients with advanced disease, the regulatory agency Mondayexpanded the label for the aerosol treatment.
Genentech, of South San Francisco, received approval of Pulmozyme(dornase alfa) in December 1993, but its use had been restricted formild to moderate cystic fibrosis patients, who have better than 40percent lung function.
After reviewing data from a three-month trial of 320 patients withless than 40 percent lung function, the FDA's Pulmonary AllergyDrug Advisory Committee in October voted 8 to 3 in favor ofrecommending approval of an expanded label for the drug. (SeeBioWorld Today, Oct. 10, 1996, p. 1.)
Cystic fibrosis affects about 30,000 people in the U.S. The deadlygenetic disease is caused by a mutation in the cystic fibrosistransmembrane conductance regulator gene, whose protein facilitatessalt and water movement in epithelial cells. The malfunction of theprotein causes a build up of mucous, which leads to lung obstructionand infections.
Pulmozyme, recombinant human DNase, breaks down the mucousand is administered with other standard therapies to treat the disease.Genentech's 1995 sales of Pulmozyme totaled $111.3 million.
The company's stock (NYSE:GNE) closed Monday at $53.75, off$0.375. _ Charles Craig
(c) 1997 American Health Consultants. All rights reserved.