Sun Pharma and Israel-based Moebius Medical Limited announced that MM-II (Large Liposomes of DPPC and DMPC) has received Fast Track designation (FTD) from the United States Food and Drug Administration (FDA) for the treatment of osteoarthritis knee pain. MM-II confirmatory Phase 3 clinical trials are underway.
In the exchange filing, Sun Pharma shared that the FDA’s Fast Track program aims to facilitate the development and expedite the review of therapies focused on curing severe conditions and addressing unmet medical needs, potentially bringing critical new medications to patients earlier. Also, companies who get FTD for their investigational products are eligible for more frequent interactions during clinical development, potentially leading to faster approval and/or priority review.
In the meantime, as of 12:34 pm, Sun Pharma shares were trading 0.082% higher at Rs 1,828.00 on the NSE.