The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AJ201, a potential first-of-its-kind treatment for Kennedy’s Disease, also known as spinal and bulbar muscular atrophy (SBMA).

AJ201, developed by AnnJi Pharmaceutical, has already received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA). This new recognition highlights AJ201’s promise in addressing an urgent unmet need of patients, and will help speed up its development and review process.

AnnJi plans to advance AJ201 into Phase 3 clinical trials, marking an important step toward what could become the first approved therapy for Kennedy’s Disease in over 20 years.

Read the news release on AnnJi’s website: https://www.ajpharm.com/news/index/2/208?lang=en

Read the press release on PR Newswire: https://www.prnewswire.com/apac/news-releases/fda-grants-fast-track-designation-for-aj201-a-first-in-class-therapy-for-kenndys-disease-302592267.html