Sun Pharma, Moebius Medical get USFDA Fast Track designation for MM-II for osteoarthritis knee pain

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-06T14:59:26+05:30 | Updated On 6 Sept 2024 2:59 PM IST

Sun Pharma Winlevi cream 1% reduces Sebum levels

Mumbai: Sun Pharma and Israel-based Moebius Medical Limited have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain.

Planning for confirmatory Phase 3 clinical trials for MM-II is underway.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs in order to potentially bring important new medicines to patients earlier. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review.

“As we enter Phase 3 development, we are very encouraged by the FDA’s decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis,” said Marek Honczarenko, MD, PHD, Senior Vice President, Head Global Development at Sun Pharma.

Moshe Weinstein, CEO of Moebius Medical, added, “This Fast Track Designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released Phase 2b data, which showed MM- II’s potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.”

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.

sun pharmasun pharma newsMoebiusUSFDAosteoarthritis knee pain

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751