FDA Grants Breakthrough Therapy Designation to SAB Biotherapeutics for Influenza Immunotherapy

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SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

SAB Biotherapeutics, a US-based clinical-stage biopharmaceutical company, announced on April 18, 2023 that FDA has granted breakthrough therapy designation to SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients. FDA also granted the treatment fast track designation on April 13, 2023.

SAB-176 is a fully human, multi-epitope-binding, broadly neutralizing immunoglobulin antibody therapeutic being developed for several influenza indications, including treatment of high-risk patient populations as well as pre- and post-exposure prophylaxis.

FDA’s breakthrough therapy designation expedites the development and review of a medicine that is intended to treat a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over therapies currently available.


“Influenza continues to pose considerable health concerns both in the [United States] and on a global scale. This [b]reakthrough [t]herapy designation signifies an important step forward in our fight against this disease," said Eddie Sullivan, co-founder, president, and CEO of SAB Biotherapeutics, in a company press release. "Even though both designations can be requested early in development, the requirements for [b]reakthrough [t]herapy designation are higher than those for the [f]ast [t]rack program. For [b]reakthrough [t]herapy designation, the improvement demonstrated must be substantial. We are proud that, based on generated preclinical and clinical evidence, SAB-176 has received both [b]reakthrough and [f]ast [t]rack designations, a combination rarely seen. These designations further assure us that SAB-176 has a clear regulatory and clinical development path to progress this important therapeutic.”

Source: SAB Biotherapeutics