This year marks 30 years since the approval of the biologic dornase alfa, a recombinant DNA degrading enzyme for the treatment of cystic fibrosis. Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase) which selectively cleaves DNA and degrades extracellular DNA in the lungs of people with cystic fibrosis. Dornase alfa is produced by genetically engineered CHO cells and purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons.
Genentech’s dornase alfa (brand name Pulmozyme) gained market approval in 1993 and is currently used as a mucolytic to treat pulmonary disease (the major cause of morbidity and mortality) in cystic fibrosis. It reduces mucus viscosity in the lungs, promoting improved clearance of secretions. Pulmozyme is administered to patients by inhalation of an aerosol mist produced by a compressed air driven nebulizer or an approved nebulizer system. Pulmozyme is a standard part of cystic fibrosis care and per Genentech more than 80% of patients with cystic fibrosis are prescribed Pulmozyme each year.