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A Gilead Sciences Inc. investigational antibiotic for cystic fibrosis patients with deadly infections will be reviewed by an FDA panel Dec. 10.
The Foster City-based drug developer (NASDAQ: GILD) said that inhalable aztreonam lysine would be reviewed by the Food and Drug Administration's Anti-Infective Drugs Advisory Committee. The drug is an antibiotic against the bacteria Pseudomonas aeruginosa, the single greatest cause of death for cystic fibrosis patients.
FDA reviewers in September 2008 recommended that the agency not approve the drug, saying that Gilead needed to do more clinical testing. Gilead last week said that a head-to-head study of the drug versus Novartis AG's tobramycin inhalation solution, or TOBI, will be fully enrolled by the end of this year and data from the study will be available in mid-2010.
Inhalable aztreonam lysine has won conditional approval in Canada and, in September, Europe under the trade name Cayston. The product will be available in Germany and the United Kingdom in early 2010, Gilead has said.
Gilead also is seeking approval from drug regulators in Australia, Switzerland and Turkey.
The drug has "orphan" status in the United States and Europe, granted to products that treat disorders that affect less than 200,000 people. The designation gives the product seven years of market exclusivity and possible tax breaks while under development.
<b>Is anyone like me and use the aztreonam version for injection via nebuliser?</b>
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The Foster City-based drug developer (NASDAQ: GILD) said that inhalable aztreonam lysine would be reviewed by the Food and Drug Administration's Anti-Infective Drugs Advisory Committee. The drug is an antibiotic against the bacteria Pseudomonas aeruginosa, the single greatest cause of death for cystic fibrosis patients.
FDA reviewers in September 2008 recommended that the agency not approve the drug, saying that Gilead needed to do more clinical testing. Gilead last week said that a head-to-head study of the drug versus Novartis AG's tobramycin inhalation solution, or TOBI, will be fully enrolled by the end of this year and data from the study will be available in mid-2010.
Inhalable aztreonam lysine has won conditional approval in Canada and, in September, Europe under the trade name Cayston. The product will be available in Germany and the United Kingdom in early 2010, Gilead has said.
Gilead also is seeking approval from drug regulators in Australia, Switzerland and Turkey.
The drug has "orphan" status in the United States and Europe, granted to products that treat disorders that affect less than 200,000 people. The designation gives the product seven years of market exclusivity and possible tax breaks while under development.
<b>Is anyone like me and use the aztreonam version for injection via nebuliser?</b>
Watching this youtube clip also the art of dance <a target=_blank class=ftalternatingbarlinklarge href="http://www.youtube.com/watch?v=maJQ1ls6310">http://www.youtube.com/watch?v=maJQ1ls6310</a>