Innovative drug for multiple sclerosis! Novart's off-the-skin injection-targeted B-cell therapy Kesimpta has significant efficacy in newly diagnosed patients!

!--, September 12, 2020 // -- Novartis recently announced the evaluation of the multiple sclerosis drug Ke at the 8th ACTRIMS-ECTRIMS Joint Conference MSVirtual2020 New post-mortem data from two key Global Phase III studies (ASCLEPIOS I, II, n-615) on the efficacy and safety of newly diagnosed multiple sclerosis (RMS) patients, as well as ongoing safety studies.
data further support Kesimpta's preferred treatment for RMS adults.
Kesimpta is a new targeted B-cell therapy approved by the FDA in August as a subcute injection for the treatment of adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission-relieving diseases, and active secondary progressive diseases.
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.
clinical data show that very high efficacy and similar safety compared to the oral drug Aubagio (teriflunomide) 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.
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.
data from two key Phase III ASCLEPIOS studies show that Kesimpta significantly reduces the risk of recurrence compared to Aubagio, significantly reducing confirmed disability progression, Gd-T1 brain injury, and new/expanded T2 lesions.
post-mortem analysis also showed that Kesimpta may have curbed new disease activity in RMS patients.
is committed to bringing Kesimpta to patients around the world, and more regulatory filings are under way around the world, with Kesimpta expected to receive regulatory approval in Europe by the second quarter of 2021.
post-mortem analysis, published at the conference, assessed Kesimpta's efficacy and safety in the subgroup of patients with early RMS (newly diagnosed and untreated ) patients. baseline characteristics of the
national diagnosis (within 3 years prior to screening), primary treatment (previously not treated for disease correction (DMT)) sub-groups are typical characteristics of patients with early multiple sclerosis (middle age and duration of multiple sclerosis since diagnosis are 36 years and 0.35 years, respectively).
results show that Kesimpta significantly reduced the annualized recurrence rate (ARR) by 50.3% (0.09 vs. 0.18; p.lt;0.001) compared to Aubagio.
(2) compared to Aubagio, Kesimpta significantly reduced the average number of T1 lesions by 95.4% (0.02 vs. 0.39; p. lt;0.001), significantly reducing the average number of new or expanded T2 lesions by 82.0% (0.86 vs. 4.78; p.lt;0.001).
(3) compared to Aubagio, Kesimpta reduced the relative risk of disability deterioration (CDW) by 38% (P-0.065) and CDW by 46% (P-0.044).
post-mortem analysis presented on the same poster at the MSVirtual 2020 conference showed that Kesimpta was treated for no disease in the first year (0-12 months) and second year (12-24 months) compared to Aubagio in the same newly diagnosed group of first-time patients (NEDA-3: no recurrence, no MRI injury, no disability deterioration) significantly increased by more than 3 times (47.0% vs 24.7%, p.001) and more than 14 times (92.1% vs 46.8%, p.001), respectively).
, Kesimpta's security is similar to Aubagio's.
safety analysis of the ongoing PHASE IIIB ALITHIOS trial (n=1873) reported long-term treatment with Kesimpta in RMS patients.
THE ALITHIOS trial includes patients who continue to be treated with Kesimpta from phase III ASCLEPIOS trials or Phase II APLIOS trials (continuous), or patients who switch from Aubagio in the ASCLEPIOS trial to Kesimpta (New Switch).
results show no new safety signals, highlighting that Kesimpta's safety in RMS patients is consistent with the data reported in the core study.
, another analysis of the combined ASCLEPIOS trial showed the prognostic value of serum nerve wire light chain (NfL) in assessing the future course of disease in RMS patients.
value of serum NfL is also supported by ALIOS studies that show a clear association between NfL and disease activity, whether it's new Gd-T1 lesions or relapses.
, of the University of Pennsylvania, said: "These encouraging data suggest that newly diagnosed and first-time patients have the potential to benefit from reduced disease activity when treated with Kesimpta.
."
Krishnan Ramanathan, global program leader for neuroscience at Novart, said: "Overall, these data add a wealth of evidence that Kesimpta is a powerful B-cell therapy that provides good safety for RMS patients, including those newly diagnosed or previously treated.
is committed to reimagining care to bring innovative treatment options to people with the disease.
"!--/ewebeditor:page--!--ewebeditor:page"--Kesimpta, as a new generation of B-cell depletors, has faster B-cell depletion and retains the immunity of the beneficial safety features, The drug, which also has the convenience of self-administration with monthly subsurfic injections, is 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 source: Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumab) in diagnosed newly treatment-naïve adults with relapsing multiple sclerosis !--/ewebeditor:page--.