The FDA has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. The news has sent cheers among those people who were waiting for a sure cure for “Cystic Fibrosis” in the United States.

TOBI Podhaler is manufactured by the New Jersey based drug giant Novartis and is being marketed by East Hanover. Meanwhile Novartis has expressed its joy over the drug approval and reiterated their willingness to serve American people.

It is important to underline here that Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. According to reports there are millions of people in the world who are suffering from this disease. The disease is badly known for deteriorating human health. In Cystic Fibrosis the respiratory tract of the individual forms thick and sticky mucus in large volume blocking the lungs and airways. The formation and buildup of thick and sticky mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs.

The approved TOBI Podhaler is a plastic, handheld inhaler device containing a dry powder formulation of tobramycin, an antibiotic widely used across the world to treat P. aeruginosa infection. Individuals who are prescribed with this inhaler need to inhale it twice daily for 28 days. The patients are then required to stop it for next 28 days and then resume it.

While briefing about the approval Edward Cox, MD, MPH, and director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research says “Today’s approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa. This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”

According to reports from sources the safety and efficacy of the inhaler was established in a randomized, placebo-controlled and blind clinical trial established in a study of 95 pediatric and adult patients with cystic fibrosis. The primary end point of the study was to assess and determine the improvement in the functioning of lung and respiratory tract by measuring the change in forced expiratory volume in one second (FEV1). The study revealed that patients treated with TOBI Podhaler experienced a statistically significant increase of 12.5 percent in FEV1 compared to 0.09 percent in patients treated with placebo.