"Reducing damage and strengthening repair"! Besttime Squibb Multi-Astal Sclerosis New Drug: Oral S1P Receptor Regulator Zeposia Approved by u.S. European Union

May 28, 2020 /
BiovalleyBIOON/ -- The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of recurrent-remission-remission multiple sclerosis (RRMS) adult patients with active diseases (defined as clinical or imaging characteristics)The drug, which is taken daily, will provide a new oral treatment option for the community of RRMS patients in Europe to help address the disease's characteristic recurrence and brain damageZeposia is an amoethanol-1-phosphate (S1P) receptor regulator that selectively binds to S1P subtypes 1 (S1P1) and 5 (S1P5) with high affinityIn particular, with this EU approval, Zeposia became the only S1P receptor regulator approved for the treatment of patients with active RRMS: the first dose observation was not required for most patients when starting treatmentFirst dose monitoring is only recommended for high-risk patients with certain congenital heart diseasesDue to the possibility of a brief drop in heart rate and room conduction delay, a dose increment scheme should be used to reach the maintenance dose of Zeposia from day 1 to 7in the United States, Zeposia was approved on March 25 this year to treat adult recurrent multiple sclerosis (RMS), including clinically isolated syndrome, recurrent recurrent diseases, and active secondary progressive diseasesZeposia was developed by Xinji, which also marks the first drug approved in the U.Sand european Union by Shiguibao since it completed its acquisition of the new base, and will expand Its Shimigipot's franchise in the field ofimmunology"Today's european commission approval provides an opportunity for patients with active RRMS to use Zeposia as a new, first-line treatment, which is a significant step forward," said DrSamit Hirawat, Chief Medical Officer,'s Perido Meishi, Chief Medical OfficerResults from the of phase III clinical trials confirm that Zeposia can significantly improve relapse and brain damage caused by this devastating disease We will work closely with all stakeholders to ensure that eligible European patients can start benefiting from Zeposia as soon as possible "
this approval, based on data in clinical trials of randomized, positive drug-controlled PHASE III SUNBEAM and RADIANCE Part B
The two trials were conducted in more than 2,600 patients in 150 clinical centers in more than 20 countries In 2 studies, Zeposia showed significant efficacy compared to Avonex (interferon beta-1a), a key clinical indicator of disease activity, compared to Avonex (interferon beta-1a), with the following data being: (1) in the SUNBEAM trial, compared to Avonex, Zeposia Treatment 1 In the RADIANCE trial, Zeposia treatment decreased ARR by 38% compared to Avonex for 2 years (;( absolute ARR:0.17 vs 0.28) in the RADIANCE trial also reduced the number of brain damage and the size of the lesions compared to Avonex The specific data are: (1) In the SUNBEAM trial, the number of T1-weighted radon-enhanced (GdE) brain injury (0.16 vs 0.43) in Zeposia and Avonex decreased by 63% compared to Avonex, and the number of new or enlarged T2 injuries (1.47 vs 2.84) decreased by 48% (2) In the RADIANCE trial, the number of T1-weighted radon-enhanced (GdE) brain injury (0.18 vs 0.37) in Zeposia compared to Avonex decreased by 53% and the number of new or enlarged T2 injuries (1.84 vs 3.18) decreased by 42% compared to Avonex in addition, Zeposia showed a decrease in the percentage change in total brain capacity (WBV) relative to the baseline compared to Avonex (SUNBEAM trial, 1 year of treatment: -0.41% vs -0.61%; in the RADIANCE trial, treatment for 2 years: -0.71% vs -0.94%) in 2 trials, Zeposia demonstrated manageable safety and tolerance Pedro Carrascal, president of the European Multiple Sclerosis Platform, said: "Multiple sclerosis is an unpredictable and often disabling disease that affects about 700,000 people in Europe We are pleased that patients now have another treatment that could potentially slow the progression of this decaying disease "
multiple sclerosis (MS) is a disease in which the immune system attacks protective myelin that covers the nerves Myelin damage can disrupt communication between the brain and the rest of the body Eventually, the nerves themselves may deteriorate, a process that is currently irreversible Multiple sclerosis affects about 2.5 million people worldwide and about 700,000 people in Europe recurrent remission multiple sclerosis (RRMS) is characterized by clearly defined episodes of neurofunctional deterioration, which are often referred to as relapse, flares, or exacerbation of the disease, followed by partial or full recovery periods (remission periods), during which symptoms are partially or completely remission withno apparent progression of the disease RRMS is the most common course of disease when diagnosed About 85% of patients were initially diagnosed with RRMS, while 10-15% were progressive MS Zeposia's active pharmaceutical ingredient, ozanimod, is an oral S1P receptor regulator that selectively binds S1P1 and S1P5 to high affinity The selective binding of ozanimod S1P1 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 neuromyelin Due to the special mechanism of action of ozanimod, the patient's immunosurveillance function is maintained The combination of ozanimod and S1PR5 activates special cells in the central nervous system, promotes myelin regeneration, and prevents synaptic defects, ultimately preventing nerve damage With 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 at present, pyridoxol-1-phosphate (S1P) receptors have become an important target for the development of new drugs in the field of MS In March 2019, Novartis Mayzent (siponimod) was approved by the U.S FDA for treatment of adult patients with RMS, including active secondary progressive sclerosis (SPMS), recurrent recurrent multiple sclerosis (RRMS), and clinical isolation syndrome (CIS) It is worth noting that Mayzent is the first drug specifically approved for active SPMS patients in the past 15 years Mayzent's active pharmaceutical ingredient is siponimod, a new generation of selective S1P receptor regulators that selectively bind to S1P receptor 1 (S1P1) and receptor 5 (S1P5) and act in the same way as Zeposia of Persimmon.com Zeposia will face competition from a number of oral drugs, such as Gilenya and Mayzent in the Oftl
, Aubagio of Sanofi, Tecfidera and Vumerity in Yanjian, Mavenclad in Merck, and Ocrevus, Roche's antibody drug, which only takes two infusions a year According to Pharma Evaluate, a pharmaceutical market research firm, Zeposia has the potential to be shortlisted for the top 10 best-selling recurrent/remission multiple sclerosis drugs of 2024, with analysts predicting that the drug will generate $966 million in sales in 2024, about half of which will come from other indications Zeposia is also being developed for a variety of immunoinflammatory conditions, including ulcerative colitis (UC), Crohn's disease (CD) and more it is worth mentioning that in March this year, Johnson and Johnson submitted a market application for ponesimod treatment of recurrent multiple sclerosis (RMS) adult patients in the European Union and the United States, a new type of oral, selective S1P1 regulator that can functionally inhibit the activity of S1P protein In the first large-scale control head-to-head phase III OPTIMUM study (NCTT024256444) for the evaluation of 2 oral drug treatments for RMS, ponesimod efficacy beat sanofi drug Aubagio (Obatier, teriflunomide, trifluoromine), an industry-leading RMS oral drug that has been available in more than 70 countries worldwide In China, Aubagio was approved in July 2018 as the first oral disease correction drug approved in China for multiple sclerosis (BioValleyBioon.com) original source: Bristol Myers Squibb Receives European Commission app roval for Zeposia (ozanimod) for The End Of Patients with Reing RinIng RinIPlus With Active WithDisease