Date: 2017-12-21

Type of information: Granting of a Fast Track status

Product name: ceftobiprole

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: Staphylococcus aureus bacteremia

Latest news:

  • • On December 21, 2017, Basilea Pharmaceutica announced  that the FDA designated its investigational drug ceftobiprole as a Qualified Infectious Disease Product (QIDP). The designation relates to the potential use of the drug in the treatment of bacterial bloodstream infections (bacteremia) caused by Staphylococcus aureus.
  • QIDP status, granted under the Generating Antibiotic Incentives Now (GAIN) Act in the United States, provides certain incentives for the development of antibiotics, such as priority review if the product is submitted for approval in the United States, and a five-year extension of certain periods of market exclusivity that may be applicable should it be approved.
  • Basilea is preparing two cross-supportive clinical phase 3 studies with ceftobiprole to support a potential future registration in the United States. Both studies will be conducted under Special Protocol Assessment (SPA) agreements with the FDA. The first study, exploring ceftobiprole in the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), is going to start shortly. The second study is going to explore the utility of ceftobiprole in the treatment of adult patients with Staphylococcus aureus bacteremia and is anticipated to start in the first half of 2018.
  • The phase 3 program receives funding of up to approximately USD 108 million from the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under contract number HHSO100201600002C.


Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes