New drug for multiple sclerosis! Novarous Kesimpta is fdatic: the first B-cell therapy to be injected once a month at home!

!--, August 21, 2020 // -- Novartis recently announced that the U.S. Food and Drug Administration (FDA) has approved Kesimp. ta (ofatumab, formerly known as OMB157) is used as an subcute injection to treat adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission-relieving disease, and active secondary progressive disease.
Kesimpta is a new targeted B-cell therapy that shows very high efficacy and similar safety compared to the oral drug Aubagio (teriflunomide) and will be the preferred treatment for a wide range of RMS patients.
Aobagio is Sanofi's oral multiple sclerosis (MS) drug and the industry's leading MS oral disease correction drug.
it's worth noting that Kesimpta is the first and only B-cell therapy that can be easily drugied and managed at home, using Sensoready auto-injection pen administration once a month.
traditionally, B-cell binders/consumption agents that treat MS are given primarily in hospitals or infusion centers, which increases the cost of the health care system and places a lifestyle burden on some patients.
Kesimpta is a very effective B-cell therapy, with monthly subsemptic injections that allow patients to treat themselves at home and avoid hospital/infusion centres, which will meet the significant needs of the RMS patient population.
goal of managing RMS is to maintain neurological function to slow the deterioration of dysfunction.
most RMS patients experience disease activity, although there are several disease-correcting therapies (DMTs) available to treat RMS.
evidence that early and efficient treatment can improve the long-term prognostication of RMS patients.
from two key Phase III ASCLEPIOS studies, Kesimpta significantly reduced the risk of recurrence, significantly reduced confirmed disability progression, Gd-T1 brain injury, and new/expanded T2 lesions compared to Aubagio.
As post-mortem analysis shows, Kesimpta may curb new disease activity in RMS patients, with no signs of disease activity in the first year (0-12 months) and second year (12-24 months) compared to Aubagio (NEDA-3: No recurrence) The risk of hair, MRI injury, and disability exacerbation increased significantly by more than 3 times (47.0% vs 24.5%, p.001) and 8 times (87.8% vs 48.2%, p.001), respectively.
, We challenge treatment models and strive to provide patients with the best treatment options," said Marie France Tschudin, President of Novarma Pharmaceuticals.
Kesimpta is a meaningful treatment option for treating RMS patients, providing high efficacy and safety, as well as more freedom to manage disease.
Kesimpta's development is a good example of our commitment, knowledge and understanding of multiple sclerosis, enabling us to identify a targeted treatment that can significantly improve patient prognosis and experience.
"ofatumab is an all-human anti-CD20 monoantigen that works by binding CD20 molecules on the surface of B cells and inducing effective B cell dissolution and depletion.
was first approved by the FDA in 2009 and sold under the commercial name Arzerra for the treatment of chronic lymphocytic leukemia (CLL), a drug that requires high-dose intravenous infusions at medical facilities.
novart then studied the treatment of RMS in a new development project because it was well known that B cells played a key role in the development of autoimmune diseases such as MS.
in RMS, ofatumab's clinical development program has been under way for 10 years, involving more than 2,300 patients worldwide as part of a rigorous study that reflects a broad patient population.
Kesimpta works in a unique way, and treatment options (drug given) are specifically designed for RMS and play a key role in outcomes.
this is a different administration option and route of administration, unlike previously approved CLL adaptations.
by Kesimpta, based on the results of 2 Phase III clinical studies (0ASCLEPIOS I, II).
both studies were head-to-head (head-to-head, H2H) studies, conducted in patients with multiple sclerosis (RMS), assessed the efficacy and safety of a 20 mg dose of Kesimpta with a daily oral Aubagio 14 mg tablet once a month.
two studies have been published in the New England Journal of Medicine (NEJM) on August 6, 2020.
results showed that Kesimpta showed a highly significant and clinically significant reduction in the number of confirmed relapses compared to Aubagio using an annual recurrence rate (ARR) assessment.
data are as follows: In 2 studies, the Kesimpta group was significantly reduced by 51% (0.11 vs. 0.22; p.001) and 58% (0.10 vs 0.25; p.001) compared to the Aubagio group.
- Disability-related secondary endpoint: Kesimpta significantly delayed the confirmed disability deterioration (CDW) time compared to Aubagio.
specific data are: in a pre-specified summary analysis, the Kesimpta group had a 34% reduction in CDW relative risk over three months compared to the Aubagio group (p=0.002) and a 32% reduction in cdW relative risk in 6 months (p=0.01).
- MRI-related secondary endpoint: Kesimpta significantly reduces the number of Gd-plus T1 lesions and new or expanded T2 lesions compared to Aubagio.
specific data were: in two studies, the relative reduction rates of T1 lesions in the Kesimpta group were 97% and 94% (average p.001), respectively, compared to the Aubagio group, and 82% and 85% in new or expanded T2 lesions (average p.001).
- Biomarker Secondary Endpoint: Kesimpta showed superiority in reducing neural axon damage compared to Aubagio, using nfL serum concentration evaluation.
, which begins with the onset of 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 endpoint: Kesimpta showed a good trend in the six-month confirmed disability improvement (CDI) incident rate compared to Aubagio, but did not achieve significant results.
- MRI-related secondary endpoint: Kesimpta had no significant difference in annual brain capacity loss rates compared to Aubagio.
- Safety: Kesimpta and Aubagio have similar overall safety, with two treatment groups with similar rates of severe infection and tumor.
most common adverse reactions in the Kesimpta group in patients with a range of 10 percent included injection-related reactions, nasopharyngitis, headache, injection site reactions, upper respiratory tract infections, and urinary tract infections.
Addition, Novarma completed the ALIOS study, an Open Label Phase II study conducted in RMS patients to determine the biological ethnosopathicity of subsopen injection drug Kesimpta through pre-charged syringes (used in ASCLEPIOS I, II studies) and auto-injection pens (for RMS patients).
results show that Kesimpta offers an efficient B-cell therapy that allows self-dosing at home using a patient-friendly auto-injector pen.
!--/ewebeditor:page--!--ewebeditor:page title"--Novartic MS portfolio Kesimpta is a new generation of B-cell depletors with faster B-cell depletion and immunity Safety features, as well as the convenience of self-administration with monthly subsurfic injections, are expected to challenge Roche's fast-growing CD20 targeted drug Ocrelizumab, which is expected to see global sales rise 57 percent to a staggering SFr3,708 million in 2019.
multiple sclerosis (MS) affects about 2.3 million people worldwide by disrupting normal functioning of the brain, optic nerve and spinal cord through inflammation and tissue damage.
The disease is usually divided into three types: relapsed-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).
about 85% of patients initially develop a recurrence type of multiple sclerosis.
in this area, Novartra's portfolio includes: Gilenya (fingolimod, S1P regulator), Mayzent (siponimod, next-generation S1P regulator), and Extavia (interferon beta-1b for subsutil injections).
addition, Sanders sells Glatapa (Gratta mine acetate, 20mg/mL, 40mg/mL) in the United States, a generic of the Teva heavy MS drug Copaxone.
() Original origin: FDA approves Novartis Kesimpta® (ofatumab), the first and only self-administrationed, targeted B-cell therapy for patients with relapsing multiple sclerosis !--/ewebeditor:page--.