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Gilead pleased with CHMP recommendation
Posted on 30/06/2009 in Pharmaceutical Company Product News
Gilead is pleased the Committee for Medicinal Products for Human Use (CHMP) has recognised the potential benefits of aztreonam lysine.
The group ? which advises the European Medicines Agency (EMEA) ? has passed a positive opinion of the 75 mg powder and solvent for the suppressive therapy of chronic pulmonary infections in patients with cystic fibrosis.
It is thought an overall decision about the treatment will be made later this year by the European Commission ? which has the authority to permit the product in the 27 EU countries.
Dr Norbert Bischofberger, executive vice-president of Gilead's research and development department, stated he was pleased the therapy was seen as being effective in addressing chronic pseudomonal airway infection.
He added this medical problem was the single greatest cause of morbidity and mortality for people with cystic fibrosis.
"We look forward to delivering this new therapeutic option to patients in the European Union as quickly as possible," Mr Bischofberger concluded.
Last month, Gilead's marketing authorisation application for regadenoson was validated by the EMEA.
The product is an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging.
