New base new oral subtype selective S1P receptor regulator ozanimod enters review in U.S. and Europe

Ozanimod is an oral 1-phosphate pyridoxanol (S1P) receptor regulator that selectively binds S1P subtype 1 (S1P1) and subtype 5 (S1P5) with high affinityUnder the Prescription Drug User Charges Act (PDUFA), the FDA will make a review decision on March 25, 2020The EMA is expected to make a review decision in the first half of 2020ozanimod was the core asset of the company that Shinji made a $7.3 billion acquisition of Receptos in 2015On u.Sregulatory issues, ozanimod was rejected by the FDA earlier in 2018 on the grounds that non-clinical and clinical pharmacological evidence was insufficient to permit reviewndA and MAA are based on efficacy and safety data for 2 multicenter, randomized, double-blind, double-simulated, positive drug control Phase III clinical studies SUNBEAM and RADIANCE PART B"The FDA and EMA are taking our applications as a key step in our efforts to bring ozanimod to patients," said Jay Backstrom, chief medical officerWe believe that ozanimod has the potential to be an important treatment option for early treatment of recurrent MS and an optimal S1P receptor regulatorit is worth mentioning that at the end of March this year, Novartis oral drug Mayzent (siponimod) was approved by the FDA for the treatment of adult patients with RMS, including active secondary progressive sclerosis (SPMS), recurrent recurrent multiple sclerosis (RRMS), and clinical isolation syndrome (CIS)Mayzent is the first and only therapeutic drug in the past 15 years specifically approved for patients with active SPMS, with the active ingredient siponimod, a new generation of selective 1-phosphate pyridoxinol (S1P) receptor regulators that selectively bind to S1P1 and S1P5 receptors and act in the same way as the new ozanimodozanimod molecular structure (Photo: Wikipedia)ozanimod is a new type of, oral, selective 1-phosphate pyridoxanol (S1P) receptor 1 (S1PR1) and receptor 5 (S1PR5) regulator, and is currently being developed for a variety of immunoinflammatory diseases, including RMS, ulcerative colitis (UC), Crohn's disease (CD)The selective binding of ozanimod S1PR1 is thought to inhibit the migration of activated lymphocytes to the inflammatory region in a particular subgroup, reducing the levels of circulating T lymphocytes and B lymphocytes that can lead to anti-inflammatory activity, thereby relieving the immune system's attack on the neuromyelinIt is worth mentioning that the patient's immunosurveillance function is maintained due to the special mechanism of action of ozanimodThe combination of ozanimod and S1PR5 activates special cells in the central nervous system, promotes myelin regeneration, and prevents synaptic defects, ultimately preventing nerve damageWith the combined effect of the two mechanisms of "reducing damage and strengthening repair", ozanimod has the potential to improve the symptoms of multiple immune diseases multiple sclerosis (MS) is a chronic inflammatory demyelinator central nervous system disease that affects about 2.3 million people worldwide The disease is caused by abnormal attacks by the body's immune system on the outer insulation and support structure of the nerves, myelin, causing inflammation and related damage This damage disrupts the exchange of information between the brain and the rest of the body, and eventually the nervous system itself deteriorates, a process that is now irreversible The symptoms and signs of the patient can vary greatly, depending on the number of injuries and the affected nerves Some patients may lose the ability to walk independently, while others may experience prolonged remission without new symptoms The average age of multiple sclerosis is generally between 20 and 40 years old, which is the main cause of non-traumatic disability in the young and middle age group RMS is the most common type of MS, characterized by recurrent episodes, followed by a period of significant partial or complete remission during which symptoms are partially or completely improved and there is no significant progression in the disease RMS accounts for about 85% of the total number of first-time patients, while progressive MS accounts for about 10-15% original origin: US FDA and EMA Accept Applications for Ozanimod for the Treatment of Reinglaps of Multiple Sclerosis