Zevtera(TM) (ceftobiprole medocaril), the novel anti-MRSA broad-spectrum antibiotic
Zeftera (Ceftobiprole Medocaril)
Trade name of the product:
Pharmaceutical active ingredients:
Available forms, composition and doses of Zeftera:
Injectable; Injection; Ceftobiprole Medocaril 500 mg
Indications and usages, anatomical therapeutic chemical and diseases classification codes:
J01DI01 - Ceftobiprole Medocaril
Pharmaceutical companies: manufacturers, researchers, developers, local distributors and suppliers:
New Drugs Online Report for ceftobiprole
Generic Name: ceftobiprole
Trade Name: Zevtera (EU), Zeftera (US)
Entry Type: New molecular entity
Development and Regulatory status
UK launch Plans: Available only to registered users
Actual UK launch date: May 2015
May 15: Launched in the UK .
Jan 15: UK launch planned for 2015 but no exact dates known yet .
Jun 14: Basilea are currently focused on preparing the launch of ceftobiprole for treatment of community and hospital-acquired pneumonia in Europe with a pharmaceutical distributor or contract sales organisation. They anticipate that ceftobiprole will be available in the first key EU markets in 2H 2014 .
Jun 14: Basilea confirm they have no current plans to file in the US, as they will not launch a new PIII study without a US partner .
Oct 13: Approved in the EU for the treatment of hospital-acquired pneumonia (excluding ventilator-associated pneumonia) and community-acquired pneumonia in adults .
Aug 13: The FDA has indicated that their current guidelines mandating two pivotal trials per indication are still valid which will delay approval in the US 
Jul 12: Filed in EU under the decentralized procedure for the treatment of pneumonia in hospitals. The submission is supported by 2 PIII studies of first- line empiric ceftobiprole vs single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired (nosocomial) pneumonia .
Jan 12: There are no further development plans for ceftobiprole in community-acquired pneumonia .
Jan 12: Basilea will finalise filing plans for the US upon additional discussions with the FDA .
Jan 12: Plan to file in EU in 2H 2012 for treatment of pneumonia in the hospital setting .
Sep 10: Basilea says that its soon-to-be ex-partner J&J is to discontinue sales of ceftobiprole for the treatment of complicated skin and soft tissue infections in Switzerland following problems it has had elsewhere in getting the drug approved; Swissmedic has been asked by J&J to withdraw its sales licence based on "the unfavorable assessments of the marketing authorisation applications" in the US and EU. J&J has also put in requests for withdrawals of marketing applications in Russia, Ukraine and Azerbaijan, the remaining countries in which ceftobiprole is currently approved. Basilea said that the decision to discontinue sales of the drug in the Swiss market "does not preclude the submission of a new application for marketing authorisation in the future" .
Feb 10: Johnson & Johnson has terminated its agreement with Basilea to develop & co-promote ceftobiprole (2). Basilea claims that J & J breached the licence agreement & had submitted a Request for Arbitration in Feb 09. The arbitration decision is anticipated before the end of 2010 (3).
Phase III in EU and US (1)
Trial or other data
Jun 15: Basilea Pharmaceutica has launched its new broad-spectrum antibiotic cephalosporin Zevtera across the UK for the first-line treatment of serious bacterial pneumonia. In clinical trials, Zevtera showed non-inferiority to currently used antibiotics for community-acquired and hospital-acquired pneumonia, and post-hoc-analyses of the data also show an early clinical response for Zevtera compared to a standard combination of antibiotics. On the safety side, Zevtera was also found to be well-tolerated, the most common side effects (reported by 3% or more patients) being nausea, vomiting, diarrhoea, infusion site reactions, hypersensitivity and taste impairment .
Oct 07: Basilea announce top-line results from a PIII trial (NCT00210964) involving 781 pts. Ceftobiprole medocaril was non-inferior to combination therapy with ceftazidime and linezolid for the treatment of nosocomial pneumonia. In the clinically evaluable population, clinical cure was achieved by 69% of ceftobiprole medocaril recipients & 72% of ceftazidime plus linezolid recipients; non-inferiority of ceftobiprole medocaril was also established in the intent-to-treat population analysis. When pts with ventilator-associated pneumonia (VAP) were excluded, the cure rates in the clinically evaluable population were 77% & 76% in the ceftobiprole & combination groups, respectively. However, cure rates with ceftobiprole medocaril were lower in pts with VAP & noninferiority could not be established. Sub-group analyses indicated that certain pts characteristics influenced patient outcomes in VAP pts. The largest difference in cure rates occurred in pts below the age of 45 years & with increased renal function. In the ceftobiprole group, there were more male pts with underlying conditions, including severe head trauma [8,9].
Evidence Based Evaluations
Available only to registered users
BNF Category: Cephalosporins, carbapenems and other beta-lactams (05.01.02)
Pharmacology: Novel cephalosporin
Epidemiology: Hospital-acquired pneumonia is defined as a new infection of lung parenchyma appearing more than 48 hours after admission to hospital. It occurs mostly in pts who are severely debilitated, immunocompromised or mechanically ventilated; mortality rate for pneumonia in hospitalised pts is 6-12% .
Indication: Bacterial infections
Additional Details: hospital-acquired/hospitalised community-acquired pneumonia
Method(s) of Administration
US Name: Basilea
Anticipated commissioning route (England) CCG
High cost drug list? No
Tariff In tariff
Implications Available only to registered users