Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment of chronic hepatitis delta, for which no approved therapies currently exist in the U.S., the company announced in a press release.
“Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the United States creates a major unmet need for patients,” Keting Chu, MD, PhD, founder and CEO of Bluejay Therapeutics, said in the release. “Breakthrough therapy designation recognizes the potential of brelovitug to transform the lives of people living with chronic HDV. We look forward to initiating a global pivotal trial as soon as possible to meet our goal of improving patients’ lives.”
Brelovitug (BJT-778) is a fully human immunoglobulin G1 monoclonal antibody designed to target hepatitis B surface antigen and neutralize and remove HBV and HDV virions. The company reports that brelovitug has demonstrated immunomodulatory functions among patients with chronic HBV, which contribute to functional cure in combination with other agents.
The current breakthrough designation follows orphan and PRIME designation granted by the European Medicines Agency.
The FDA grants breakthrough designation to expedite development of drugs or devices intended to treat serious conditions and supported by clinical evidence indicating that the product may demonstrate substantial improvement over currently available drugs or devices. Breakthrough designation is intended to accelerate drug/device development, assessment and review for premarket approval, 510(k) clearance and de novo marketing authorization, while still meeting FDA standards for safety and effectiveness.
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