Gilead Sciences (GILD) Announces European CHMP Positive Opinin for Aztreonam Lysine
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorisation Application for aztreonam lysine 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 18 years and older. The opinion is for conditional approval, contingent on the successful completion of an ongoing study.
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. Gilead expects the European Commission to issue its decision on the marketing authorization for aztreonam lysine later this year. Aztreonam lysine was previously reviewed by the CHMP in March and received a negative opinion, which Gilead appealed.
Gilead has also submitted applications for marketing approval of aztreonam lysine in Australia, Canada, Switzerland and Turkey. In the United States, the U.S. FDA has informed Gilead of the need to conduct an additional clinical study before the company can resubmit its New Drug Application. Gilead has two ongoing clinical studies evaluating the product among patients with CF.
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. Gilead expects the European Commission to issue its decision on the marketing authorization for aztreonam lysine later this year. Aztreonam lysine was previously reviewed by the CHMP in March and received a negative opinion, which Gilead appealed.
Gilead has also submitted applications for marketing approval of aztreonam lysine in Australia, Canada, Switzerland and Turkey. In the United States, the U.S. FDA has informed Gilead of the need to conduct an additional clinical study before the company can resubmit its New Drug Application. Gilead has two ongoing clinical studies evaluating the product among patients with CF.
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