Pulmozyme For Severe CF Patients

Genentech's Pulmozyme (dornase alfa) improved forced-expiratory volume in one second (FEV1) by 9.4% in cystic fibrosis patients with severe lung disease after three months of treatment compared to a 2.1% improvement in placebo-treated patients, according to a study presented at the North American Cystic Fibrosis Conference in Orlando, Florida.

The 320-patient trial assigned patients to receive either 2.5mg of Pulmozyme once-daily or placebo, as well as their usual treatment regimen. In addition to the improvement in FEV, the therapy was associated with a 12.4% increase in forced vital capacity, compared to a 7.3% improvement in placebo patients, said the firm. With respect to the other measurable outcomes, said Genentech, the study did not find a significant difference in exacerbations of CF requiring antibiotics or the rate of events requiring hospitalization.

Pulmozyme is approved by the US Food and Drug Administration for the treatment of mild to moderate pulmonary dysfunction and its labelling notes that the product did not produce a benefit in severe patients. The company plans to file results of the study to expand the labelled patient population for Pulmozyme.