FDA Panel Backs Tobramycin Powder for Cystic Fibrosis
Reviewers had previously questioned drug’s efficacy (Sept. 5)
Reuters reported on September 5 that a panel of advisers to the FDA had voted 13 to 1 that tobramycin inhalation powder (TIP) was safe and effective for the treatment of a lung infection linked to cystic fibrosis. The FDA usually follows the panel’s recommendations, although it is not required to do so. A final decision will be made later.
Novartis hopes to win approval of the antibiotic powder, which is taken with an inhaler, as a more convenient alternative to its older version of tobramycin (TOBI), which requires the use of a nebulizer machine.
Previously, clinical reviewers at the FDA had questioned whether the data showed that TIP truly helped cystic fibrosis patients breathe better, especially compared with TOBI.
Cystic fibrosis affects 30,000 people in the U.S.
For more information, visit the Reuters Web site.