Basilea’s Ceftobiprole Receives QIDP DesignationBy
The US Food and Drug Administration (FDA) has designated cefrobriprole, an investigational drug from Basilea Pharmaceutica, a Swiss biopharmaceutical company specializing in anti-infective and oncological medicines, as a Qualified Infectious Disease Product (QIDP), a recent designation by the FDA to encourage development of new antibiotics.
The designation relates to the potential use of the drug in treating bacterial bloodstream infections (bacteremia) caused by Staphylococcus aureus.
QIDP status, granted under the Generating Antibiotic Incentives Now Act in the US, provides certain incentives for developing antibiotics, such as priority review if the product is submitted for approval in the US, and a five-year extension of certain periods of market exclusivity that may be applicable should it be approved.
Source: Basilea Pharmaceutica