Gilead says cystic fibrosis drug trial meets main goal
Wed May 30, 2007 6:40 AM IST
(Reuters) - Gilead Sciences Inc. said the second late-stage trial of its inhaled treatment for a genetic disease, cystic fibrosis, met its main goal following a 28-day treatment.
The trial involved 164 cystic fibrosis patients with pseudomonas infection who received a 28-day treatment course of 75 milligrams of aztreonam lysine versus a dummy pill.
The biopharmaceutical company said the patients experienced significant improvements in respiratory function, as measured on a certain scale, versus those on the dummy pill.
The company noted that incidences of bad effects from the treatment, such as nasal congestion, sore throat and shortness of breath, were not significantly different between aztreonam lysine and the dummy pill.
Gilead plans to seek marketing approval from U.S regulators for aztreonam lysine in the second half of 2007.
In April, the company reported that a late-stage trial found aztreonam lysine reduced the need for inhaled or intravenous antibiotics.
Cystic fibrosis is an inherited condition in which the lungs are unable to clear themselves of mucous leading to infections that can seriously damage the lungs.
More than 30,000 people in the United States have cystic fibrosis and currently there is no known cure for it, the company said. (Reporting by Shailesh Kuber and Himani Sarkar in Bangalore)
Wed May 30, 2007 6:40 AM IST
(Reuters) - Gilead Sciences Inc. said the second late-stage trial of its inhaled treatment for a genetic disease, cystic fibrosis, met its main goal following a 28-day treatment.
The trial involved 164 cystic fibrosis patients with pseudomonas infection who received a 28-day treatment course of 75 milligrams of aztreonam lysine versus a dummy pill.
The biopharmaceutical company said the patients experienced significant improvements in respiratory function, as measured on a certain scale, versus those on the dummy pill.
The company noted that incidences of bad effects from the treatment, such as nasal congestion, sore throat and shortness of breath, were not significantly different between aztreonam lysine and the dummy pill.
Gilead plans to seek marketing approval from U.S regulators for aztreonam lysine in the second half of 2007.
In April, the company reported that a late-stage trial found aztreonam lysine reduced the need for inhaled or intravenous antibiotics.
Cystic fibrosis is an inherited condition in which the lungs are unable to clear themselves of mucous leading to infections that can seriously damage the lungs.
More than 30,000 people in the United States have cystic fibrosis and currently there is no known cure for it, the company said. (Reporting by Shailesh Kuber and Himani Sarkar in Bangalore)