FDA panel backs cystic fibrosis drug

Drug advisers on Wednesday backed a new form of Novartis AG's inhaled antibiotic that treats a lung infection linked to cystic fibrosis.

A panel of outside advisers to the Food and Drug Administration voted 13 to 1 that Novartis had demonstrated that its tobramycin inhalation powder, or TIP, was safe and effective. The FDA usually follows panel recommendations, although it is not required to do so, and will make a final decision later.

Novartis is seeking approval of the antibiotic powder, which patients can take with an inhaler, as a more convenient alternative to its older version of tobramycin called Tobi that required use of a nebulizer machine.

"I think it's wonderful there's an additional drug available. Its importance, as with any new drug, will be determined over time," said panel member Dr. Paul Auwaerter, clinical director in infectious diseases at the Johns Hopkins School of Medicine.

TIP treats a lung infection that often afflicts patients with cystic fibrosis, a genetic disease that affects about 30,000 people in the United States.

Ahead of the panel meeting, clinical reviewers from the FDA had questioned whether the data showed TIP truly helped cystic fibrosis patients breathe better, especially compared to the company's older Tobi drug.

But most panel members on Wednesday said the company had sufficiently proven TIP was just as safe and effective.

"As is often the case, the available data are imperfect," said panel member Dr. Melvin Weinstein, chief of the division of infectious diseases at the Robert Wood Johnson Medical School in New Jersey. "But that said, the efficacy appears to be similar to Tobi, and I don't see enough of a (safety) signal to prevent approval of this drug."

The tobramycin powder, administered with an inhaler, has already been approved for use in Europe and Canada. Overall sales of the "Tobi" inhaled antibiotic - which includes the inhaled powder and the nebulized solution - were $296 million in 2011, Novartis said.

Cystic fibrosis causes the thin layer of mucus that helps keep lungs free of germs to thicken, clogging airways and damaging the lungs. The average life expectancy for the disease is 37 years as damage to the lungs progresses and limits the ability to breathe.

The thickening of mucus results in life-threatening infections that must be treated with antibiotics. Novartis's drug treats an infection called pseudomonas aeruginosa.

Earlier on Wednesday, Novartis shares closed up 1.3 percent at 56.65 francs in trading on the Swiss stock exchange.