Chiron has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) under the European Union's Centralized Procedure for approval to market Cubicin (daptomycin for injection).
The indication in the submission is for complicated skin and soft-tissue infections (cSSTI) where the presence of susceptible Gram-positive bacteria is confirmed or suspecteded. The filing includes safety data from two pivotal phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of Cubicin in the treatment of cSSTI, Chiron Corporation and Cubist Pharmaceuticals, Inc. have jointly announced here.
"This filing is a crucial step toward our goal of launching Cubicin in the European Union," Craig Wheeler, president, Chiron BioPharmaceuticals said adding, "Approval to market Cubicin would expand our portfolio of anti-infective products and allow us to leverage our existing sales and marketing force in the European Union to bring a potentially important new product to patients."
As a result of the filing, the EMEA Committee for Medicinal Products for Human Use (CHMP) will evaluate the application to determine whether to approve the marketing of Cubicin in all 25-member states of the European Union. In October 2003, Cubist and Chiron completed a license agreement for the development and commercialization of Cubicin in Western and Eastern Europe, Australia, New Zealand, India and certain Central American, South American and Middle Eastern countries. Under the terms of the agreement, Chiron is responsible for regulatory filings in those territories.
Cubicin is currently the only once-daily bactericidal antibiotic approved in the United States indicated for the treatment of complicated skin and skin-structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).