| Gilead Earns FDA Nod for CF Drug | | Print | |
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Foster City’s Gilead Sciences announced this week that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the company’s Cayston (aztreonam for inhalation solution) treatment for improving respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Cystic fibrosis affects the respiratory and digestive systems of about 30,000 people in the United States. Norbert Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer, said in a statement that his company was looking to get the pharmaceutical out as soon as possible. "[We] at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials," said Bischofberger. "We look forward to making Cayston available to the cystic fibrosis community as soon as possible." The company said it planned to make the drug available as soon as early March. There are some warnings connected with the treatment, however. The company stated, that the drug's safety and efficacy have not been established in children younger than seven, for instance. The company is also launching the Cayston Access Program, a call center to assist patients and care providers with information. The center can be reached at 1-877-722-9786. |
| Last Updated on Thursday, 29 April 2010 07:48 |
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