A new drug for multiple sclerosis! Novarhua once a month of ofatumab III clinical efficacy beat Sanofi oral drug Aubagio!

!-- Webeditor:page title"--August 07, 2020 // -- Novartis recently announced that the New England Journal of Medicine (NEJM), an international authoritative medical journal, ) Positive results from two Phase III clinical studies (ASCLEPIOS I, II) on the treatment of multiple sclerosis (RMS) with monoantigenic drug of often oatumumab (OMBI157) have been published online.
data show that ofatumumab (once a month subsolution, 20 mg) significantly reduces the risk of recurrence and confirmed disability deterioration, significantly reduces active or new brain damage, and has similar safety compared to the commonly used oral drug Aubagio (teriflunomide, trifluamine, once daily, 14mg tablet).
is a new type of B-cell therapy used to treat adult patients with RMS and is currently under review by regulators in the UNITED States and the European Union.
if approved, ofatumumab will be the first B-cell therapy that can easily self-medicat at home (using an auto-injection pen to inject once a month under the skin) and has the potential to be the preferred treatment for RMS patients.
is expected to be approved in the United States in September 2020 and in Europe in the second quarter of 2020.
is committed to bringing ofofatumumab to patients around the world, and regulatory applications are under way in other countries. Krishnan Ramanathan, global program leader at
Novarro Neuroscience, said: "The ASCLEPIOS I and II studies demonstrate the effectiveness and safety of of ofatumumab and the potential of the drug as the preferred treatment for RMS patients to continue their lives.
of our commitment to advancing scientific development, researching potential treatments, reimagining care, and addressing all of the important unsolved needs of the RMS journey.
Professor Stephen L. Hauser, co-chair of the ASCLEPIOS I and II Research Steering Committee and director of the Weir Institute of Neuroscience at the University of California, San Francisco, said: "Two ASCLEPIOS studies have found that ofatumab significantly reduces new inflammation, clinical recurrence and progression events.
a separate post-mortation analysis showed that nearly 90 percent of patients showed no signs of disease activity in the second year of treatment.
ofatumumab is a potential new option for RMS patients, with a higher efficacy, 20 available safety, and self-dosing once a month without infusion than Aubagio.
"ofatumumab" regulatory application is based on positive results from the two Phase III clinical studies mentioned above (ASCLEPIOS I, II).
both studies were head-to-head (H2H) studies conducted in RMS patients who assessed the efficacy and safety of a monthly subsokin injection of 20 mg dose of of ofatumumab and a daily oral Aubagio 14 mg tablet.
Abagio is an oral multiple sclerosis drug sold by Sanofi and the industry's leading MS oral disease remediation drug.
results are as follows: - Main endpoint: Annual recurrence rate (ARR) assessment, the number of confirmed relapses compared to Aubagio showed a highly significant and clinically significant reduction.
data were: in two studies, the ARR group was significantly lower than the Aubagio group by 51% (0.11 vs. 0.22; p.001) and 58% (0.10 vs. 0.25; p.001).
- Disability-related secondary endpoint: ofatumumab significantly delayed the confirmation of disability deterioration (CDW) compared to Aubagio.
data are: in a pre-specified summary analysis, the relative risk of CDW decreased by 34% compared to the Aubagio group by 34% (p-0.002) and the relative risk of CDW for 6 months by 32% (p-0.01).
- MRI-related secondary endpoint: ofatumumab significantly reduced by -enhanced (Gd-plus) T1 lesions and new or expanded T2 lesions compared to Aubagio.
data are as follows: in two studies, the relative reduction rate of -enhanced (Gd-plus) T1 lesions compared to the Aubagio group was 97% and 94% (average p.001), and the relative reduction rate of new or expanded T2 lesions was 82% and 85%, respectively (average p.001).
- Biomarker Secondary Endpoint: Using nerve wire light chain (NfL) serum concentration evaluation, ofatumumab showed the advantages of reducing neural axon damage compared to Aubagio.
axon loss, which begins with the onset of the disease, is a harmful result of inflammation of the central nervous system (CNS) and a key determining factor for irreversible neurological dysfunction in MS patients.
- Disability-related secondary endpoints: Ofatumumab showed a good trend in the rate of disability improvement (CDI) events confirmed over a six-month period compared to Aubagio, but did not achieve significant results.
- MRI-related secondary endpoint: There was no significant difference in annual brain capacity loss compared to Aubagio.
- Safety: Ofatumumab is similar to the overall safety of Aubagio, with severe infections and tumor rates similar in two treatment groups.
most common adverse reactions that occurred in the often-of-atumumab group in up to 10% of patients included injection-related reactions, nasopharyngitis, headache, injection site reactions, upper respiratory tract infections, and urinary tract infections.
ofatumumab is an all-human anti-CD20 monoantrone that works by binding CD20 molecules on the surface of B cells and inducing effective B cell dissolution and depletion.
, atatumumab has been approved for the treatment of chronic lymphoblastic leukemia (CLL), which is sold under the brand name Arzerra.
But Novarro has designated a new research and development code OMB157 for ofatumab to develop as a new generation of B-cell depletors, which have faster B-cell depletion and retain the potentially beneficial safety properties of immunity, while having a monthly The convenience of self-administration through subsoccupal injections is expected to challenge Roche's fast-growing CD20-targeted drug ocrelizumab, which will see global sales rise 57 per cent to a staggering CHF 3,708 million in 2019.
!--/ewebeditor:page-!--ewebeditor:page title"--the IIb positive results for patients with multiple sclerosis (MS) were published in 2014, showing a significant reduction in the number of new brain injuries in the first 24 weeks after delivery.
December 2015, Novarro acquired the right from Genmab to all of its adaptations, including MS.
August 2016, Novarro launched Phase III of of the UATumab Treatment for Multiple Sclerosis (RMS).
MS portfolio of multiple sclerosis (MS) disrupts the normal functioning of the brain, optic nerve and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide.
The disease is usually divided into three types: recurrent-remission multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS, commonly defined as cognitive and physical changes and the overall accumulation of disability), and primary progressive multiple sclerosis (PPMS).
85 percent of patients in the U.S. initially develop multiple sclerosis of the type of recurrence.
in this area, Novartis's portfolio includes: Gilennya (fingolimod, S1P regulator), Mayzent (siponimod, next-generation S1P regulator), extavia (subderapor injection interferon beta-1b).
addition, Sandex sells Glatopa (20mg/mL acetate, 40mg/mL), a generic drug for the heavy MS drug Copaxone, in the United States.
() Source: Novartis Announces NEJM Publications of Phase III ASCLEPIOS Trials Showing Superiority of the uatumumab in patients with relapsing multiple sclerosis !--/ewebeditor:page.