Swiss Regulatory Authority Grants Accelerated Assessment of Planned Market Authorization Application for Ceftobiprole
Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that Swissmedic granted Janssen-Cilag AG, a Johnson & Johnson company, accelerated assessment of the planned market authorization application (“Beschleunigtes Zulassungsverfahren”) for ceftobiprole for the treatment of complicated skin and soft tissue structure infections.
Swissmedic accelerated assessment designation is designed to expedite the availability of treatments that address high medical needs and is granted provided all of the following criteria are fulfilled: the therapy must have promising potential for the treatment of a severely debilitating or life-threatening disease, existing therapies are insufficient or not available, and a high therapeutic benefit is expected through the use of the drug.
Dr. Anthony Man, CEO of Basilea said, “We want to make ceftobiprole available to patients and prescribers around the world as quickly as possible, and are pleased that ceftobiprole has met the requirements to receive accelerated assessment designation in Switzerland.”
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