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

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-09-06 09:29 GMT | Update On 2024-09-06 09:29 GMT

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.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

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

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

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

Similar News