November 21, 2014 | Avaxia Biologics, Inc. | LEXINGTON, Mass. | Press Release
Avaxia Biologics Receives FDA Orphan Drug Designation for AVX-470 for the Treatment of Pediatric Ulcerative Colitis
Avaxia Biologics, Inc. press release that went out this morning announcing they were granted orphan drug designation approval by the FDA for AVX-470 for ulcerative colitis. Orphan drug designation provides a number of important benefits, including 7 year marketing exclusivity once the drug is approved. Getting this designation is an important first step in the development of AVX-470 for pediatric inflammatory bowel disease.
AVX-470 is the first gut-targeted anti-TNF antibody in clinical development. The lead indication is inflammatory bowel disease (IBD), a serious disease involving chronic inflammation of the intestinal tract. Currently marketed anti-TNF drugs are highly effective for the treatment of IBD. However, despite their success, these drugs have two significant drawbacks. One is that they must be infused or injected, whereas patients prefer oral medications. More importantly, they cause rare but serious side effects, such as risk of serious infection, because they dampen the immune system throughout the body, not just in the intestines where the disease occurs.
Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases, announced today that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is a gut-targeted anti-TNF antibody, which earlier this year successfully completed a Phase 1b clinical trial in adults with active ulcerative colitis.