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
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.