Posted by Michael Wonder on 22 Dec 2017
Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of Staphylococcus aureus bacteremia
21 December 2017 - Basilea Pharmaceutica announced today that the U.S. FDA designated its investigational drug ceftobiprole as a Qualified Infectious Disease Product.
The designation relates to the potential use of the drug in the treatment of bacterial bloodstream infections (bacteremia) caused by Staphylococcus aureus.
Qualified Infectious Disease Product 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.
