Novartis snags FDA approval for antibiotic in CF patients

Novartis ($NVS) notched an FDA approval on Friday for a dry-powder formulation of an antibiotic that fights a type of bacterial infection in patients with cystic fibrosis (CF). The Swiss drug giant touts the product, TOBI Podhaler, as a way to deliver the antibiotic against Pseudomonas aeruginosa faster than existing liquid formulations given with nebulizers.

The approval comes as no surprise after the product, known generically as tobramycin inhalation powder, breezed through with a 13-1 vote at an FDA advisory committee session in September. And while nobody is calling Novartis' treatment a game-changer on par with Vertex's ($VRTX) pioneering CF drug Kalydeco, inhaled antibiotics serve a vital role combating persistent lung infections that thrive in the thick sticky mucus of those with the disease.

About 30,000 patients in the U.S. suffer from cystic fibrosis, a chronic genetic disorder that leads to breathing problems and poor digestion. The patients take a battery of up to 20 medications to control their symptoms on a daily basis, spending more than an hour and a half per day in treatment time, according to Novartis, which markets tobramycin in the U.S. in a liquid solution delivered with a nebulizer. The dry powder product uses an inhaler that requires 70% less time for treatment than the nebulized therapy, according to the company, leading to a reduction of 13 hours over the course of a 28-day treatment cycle.

"Today's approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa," stated Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler."

The FDA approval follows an efficacy study of 95 CF patients aged 6 or older with the P. aeruginosa infections. Those on TOBI Podhaler showed an increase of 12.5% in a breathing test compared with .09% among patients on placebo. Investigators tested the safety of the therapy in 487 patients, and the most common side effects included coughing up blood and mucus, lung problems, shortness of breath, mouth and throat pain, fever and headache.

- here's the FDA's release
- see Reuters' report