Biopharmaceutical startup JHL Biotech (Stock Code:6540.TWO) disclosed on Wednesday that it has filed a Phase 1 Clinical Trial Application with the Dutch Healthcare Authority for its planned dornase
alfa biosimilar, JHL1922, for the improvement of pulmonary function in cystic fibrosis patients.
* Prescribe inhaled dornase
alpha and inhaled tobramycin for maintenance pulmonary treatment of moderate to severe cystic fibrosis (CF).
He was on chronic antimicrobial therapy (inhaled colistin and oral azithromycin), as well as inhaled salbutamol, inhaled corticosteroids, dornase
alfa, pancreatic enzymes, domperidone, omeprazole, PEG 3350, multivitamins including Vitamins D and K, insulin, ursodeoxycolic acid, furosemide and amilioride.
103532 Pulmozyme (dornase
alfa) Inhalation Solution MACMIS ID #17309, FDA.GOV (Apr.
Other medications included dexamethasone, bumetanide, pantoprazole, dornase
, and insulin.
(1) Treatment of the pulmonary involvement typically includes inhaled medications [eg, hypertonic saline, tobramycin (an antibiotic), and dornase
alfa (a mucolytic)], systemic antibiotics, airway clearance, and exercise.
Acetylcysteine (Mucomyst) and guaifenesin are also helpful, but dornase
alfa (Pulmozyme) is not indicated in non-CF patients and was actually harmful in one study.
The purpose of this article is to give a brief overview of how the drug dornase
alfa (Pulmozyme (R), Genentech) affects CF, as well as how it is administered, its side effects and case studies.
For example, in children there is 16-20% adherence recorded for dietary supplementation but up to 67-84% for dornase
alpha (Modi et al 2006).
-- Sales of legacy products, including growth hormone, cardiovascular products and Pulmozyme(R) (dornase
alfa, recombinant) Inhalation Solution, increased 5 percent to $180.9 million from $171.8 million in the second quarter of 2003.
alfa (Pulmozyme) treatment reduced exacerbations in healthy cystic fibrosis patients who were 6-10 years old.
Possibly the most innovative drug to win FDA approval last year was Genentech Inc.'s dornase
alfa, which was what Hussar described as the first major advance for cystic fibrosis patients in 30 years.