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FDA Grants Orphan Drug Status to AVX-470 for Pediatric UC
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The FDA granted orphan drug designation to AVX-470 for the treatment of pediatric ulcerative colitis, the manufacturer announced today.
AVX-470 (Avaxia Biologics) is the first gut-targeted anti-tumor necrosis factor antibody in clinical development, according to the release. It is orally administered, potentially improves safety and efficacy compared with existing anti-TNF drugs, and has the potential to become a first-line treatment for inflammatory bowel disease, the release said.
“We are pleased to receive orphan drug designation for AVX-470 for treatment of pediatric UC,” Barbara S. Fox, PhD, CEO of Avaxia, said in the press release. “The drawbacks of current anti-TNF drugs are especially problematic in children. These drugs are injected or infused and may have serious side effects caused by systemic immunosuppression. As a gut-targeted antibody drug, AVX-470 avoids these drawbacks and may allow use of anti-TNF therapy earlier in the treatment of pediatric UC, with the goal of improving patient outcomes.”
A phase 1b clinical trial of AVX-470 in adults with active UC was successfully completed earlier this year, the release said.