Date: 2015-10-12
Type of information: Granting of a Market Authorisation in the EU
Product name: Zevtera®/Mabelio®
Compound: ceftobiprole
Therapeutic area: Infectious diseases
Action mechanism: antibiotic/cephalosporin. Ceftobiprole belongs to the class of antibacterial agents known as cephalosporins. Its broad spectrum activity encompasses Gram-positive and Gram-negative bacteria, including anti-pseudomonal activity similar to cefepime. The rights for ceftobiprole have been transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company, in February 2011.
Company: Basilea Pharmaceutica (Switzerland)
Disease: severe community-acquired and hospital-acquired pneumonia
Latest news: * On October 12, 2015, Basilea Pharmaceutica announced that Health Canada has approved Zevtera® (ceftobiprole medocaril) for the treatment of patients 18 years of age and older with hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP), and for the treatment of community-acquired pneumonia (CAP). * On December 22, 2014, Basilea Pharmaceutica reports that the Swiss regulatory authority Swissmedic has approved the antibiotic Zevtera® (ceftobiprole medocaril) for the treatment in adults of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). The license will be issued by Swissmedic following formal publication of the Product Information. Ceftobiprole for the treatment of pneumonia has already been approved in twelve other European countries. * On December 5, 2014, Basilea Pharmaceutica announced that its broad-spectrum antibiotic, Zevtera® (ceftobiprole medocaril)* has been launched in Germany. Zevtera® is the only antibiotic monotherapy that is approved in certain European countries for the treatment of adults with community-acquired pneumonia and hospital-acquired pneumonia (excluding ventilator-associated pneumonia) with activity against methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens including Pseudomonas spp. * On August 14, 2014, Basilea Pharmaceutica announced that the company anticipate launching Zevtera® in Germany in the second half of the year, followed by launches in other key European markets in 2015. * On October 23, 2013, Basilea Pharmaceutica has announced the approval of its antibiotic ceftobiprole in Europe. Ceftobiprole is indicated for the treatment of hospital-acquired pneumonia (excluding ventilator-associated pneumonia) and community-acquired pneumonia in adults. Ceftobiprole has broad-spectrum activity against many pathogens that cause pneumonia including Gram-positive pathogens such as penicillin-resistant Streptococcus pneumoniae (PRSP), methicillin-resistant Staphylococcus aureus (MRSA) and various Gram-negative pathogens including Pseudomonas species. Basilea submitted the ceftobiprole Marketing Authorization Application under the Decentralized Procedure (DCP) initially in 12 European Union Member States including the major markets in Europe. In accordance with the DCP, each of the involved Member States are expected to grant national authorizations within the coming months. In Switzerland, a ceftobiprole Marketing Authorization Application for the treatment of hospital- and community-acquired pneumonia in adults is currently under review by the regulatory authority Swissmedic. * On September 16, 2013, Basilea Pharmaceutica has announced that the Swiss regulatory authority Swissmedic has accepted the ceftobiprole Marketing Authorization Application for review. Basilea's submission dossier includes data from two international double-blind, randomized, controlled phase 3 studies in hospital-acquired pneumonia and community-acquired pneumonia. These studies compared the efficacy and safety of empiric ceftobiprole use versus standard-of-care single or combination antibiotic therapy. Ceftobiprole in pneumonia is currently under review with European regulatory authorities, with a decision anticipated in the second half of 2013. * On October 5, 2012, Basilea Pharmaceutica has reported that Basilea Pharmaceutica International Ltd. has received confirmation from European health authorities that the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of pneumonia in hospitals has been accepted for review under the decentralized procedure. * On July 30, 2012, Basilea Pharmaceutica has announced that is has submitted a Marketing Authorization Application (MAA) under the European decentralized procedure for ceftobiprole, a broad-spectrum anti-MRSA (methicillin-resistant Staphylococcus aureus) drug, for the treatment of pneumonia in hospitals. The submission is supported by two international double-blind randomized controlled phase III studies assessing the efficacy and safety of first-line empiric ceftobiprole versus single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired (nosocomial) pneumonia. * On January 5, 2012, Basilea Pharmaceutica announced that it will apply in the second half of 2012 for approval of its antibiotic ceftobiprole in Europe. The company has completed investigator site audits of two international double-blind randomized controlled phase III studies of ceftobiprole for the treatment of severe community-acquired and hospital-acquired pneumonia. The audits included 26 investigator sites, covering more than one third of patients of both trials. On the basis of these audits and following health authority feedback on potential filing strategies, Basilea has decided to apply in the second half of 2012 for the approval of ceftobiprole in Europe for pneumonia treated in the hospital setting. The company will finalize its filing plans for the U.S. upon additional discussions with the FDA.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2012-07-30
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2013-10-23
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
