Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), 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 (CF) 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.
“We are pleased that the CHMP has recognized the potential therapeutic
benefit of aztreonam lysine in addressing chronic pseudomonal airway
infection – the single greatest cause of morbidity and mortality for
people with cystic fibrosis,” said Norbert Bischofberger, PhD, Executive
Vice President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “We look forward to delivering this new therapeutic
option to patients in the European Union as quickly as possible.”
Gilead has also submitted applications for marketing approval of
aztreonam lysine in Australia, Canada, Switzerland and Turkey. In the
United States, the U.S. Food and Drug Administration (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.
About Cystic Fibrosis
Today, more than 70,000 people worldwide have cystic fibrosis. Cystic
fibrosis is a chronic, debilitating genetic disease. A major
characteristic of cystic fibrosis is production of abnormally thick,
sticky mucus in the lungs that traps bacteria and predisposes people
with cystic fibrosis to lung infections. Currently, there is no known
cure for cystic fibrosis, and the goal of cystic fibrosis therapy is to
control symptoms and prevent further lung damage.
About Aztreonam Lysine
Aztreonam lysine 75 mg powder and solvent for nebuliser solution is an
inhaled antibiotic candidate for people with cystic fibrosis who have P.
