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FDA Approves Novartis' TOBI Podhaler

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Novartis AG’s (NVS - Free Report) TOBI Podhaler (tobramycin inhalation powder) recently received US Food and Drug Administration (FDA) approval for the treatment of bacterial lung infection in cystic fibrosis patients caused by the Pseudomonas aeruginosa bacterium.

The approval was based on a study conducted on 95 pediatric and adult patients suffering from cystic fibrosis. Patients received TOBI Podhaler or placebo for the first 28 days of the study. After that they were treated with TOBI Podhaler.

A statistically significant increase of 12.5% in forced expiratory volume in one second (FEV1) was achieved in patients treated with TOBI Podhaler compared to 0.09% in patients treated with placebo.

Our Take

We are positive on the FDA approval of TOBI Podhaler. TOBI Podhaler’s regulatory path in the US has not exactly been smooth with the company receiving a complete response letter from the FDA in Oct 2012. Subsequently Novartis responded to the CRL. The FDA approved the drug on the basis of resubmitted application.

TOBI Podhaler is currently approved in the European Union, Canada, Switzerland and other countries. TOBI’s (TOBI nebulizer solution and TOBI Podhaler) sales in 2012 were up 7% year over year (up 9% year over year in constant currency) to $317million.

The recent bout of regulatory approvals at Novartis is encouraging. A few weeks back, the Jetrea intravitreal injection (ocriplasmin) was approved by the European Commission for the treatment of vitreomacular traction and macular hole.

Novartis carries a Zacks Rank #4 (Sell). Large-cap pharma companies that currently look better-positioned include Eli Lilly (LLY - Free Report) , Abbott Laboratories (ABT - Free Report) and Novo Nordisk (NVO - Free Report) . All three are Zacks Rank #2 (Buy) stocks.

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