New drug for multiple sclerosis! Novart Kesimpta EU is about to be approved

Novartis recently announced that the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of Kesimta for the treatment of adult patients with resophageal multiple sclerosis (RMS) with active diseases defined by clinical or imaging characteristics.
chMP's comments will now be submitted to the European Commission, which is expected to make a final review decision within two months.
August 2020, the FDA approved Kesimpta as an off-cortical injection for the treatment of adult patients with RMS, including clinical isolation syndrome, relapsed remission-relieving diseases, and active secondary progressive diseases.
January 25, 2021, Health Canada approved Kesimpta for the treatment of relapsed remission-relieving multiple sclerosis (RRMS).
Kesimpta is a new targeted B-cell therapy that shows very high efficacy and similar safety compared to the first-line drug Aubagio for multiple sclerosis (MS) 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, with 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.
Marie France Tschudin, president of Novarma Pharmaceuticals, said: "Kesimpta's positive review of CHMP underscores its potential to offer a new treatment for RMS patients in Europe that combines strong efficacy and good safety to deliver it at home.
by eliminating the need for defusion centers, Kesimpta can reduce not only the burden on patients, but also on doctors and the health care system.
Kesimpta is a reflection of our commitment to redesigning the drug for the multiple sclerosis community and we will work closely with regulators to ensure that it is available to people with multiple sclerosis in Europe as soon as possible.
", based on the results of two key Phase III ASCLEPIOS studies.
these studies reached the main endpoint, with data showing that Kesimpta reduced annual recurrence rate (AAR) by more than 50 per cent and the relative risk of confirming disability progress (CDP) by more than 30 per cent compared to Aubagio.
addition, Kesimpta significantly reduced Gd-T1 brain damage and new/expanded T2 lesions compared to Aubagio.
the results of these two studies were published in the New England Journal of Medicine on August 6, 2020.
independent post-mortem analysis showed that Kesimpta may have prevented new disease activity in RMS patients, and nearly 90 percent of patients treated with Kesimpta showed no signs of disease activity (NEDA-3) in the second year of treatment.
Kesimpta, a new generation of B-cell depletion agents with faster B-cell depletion and immunity-based safety features, as well as the convenience of self-administration with monthly subsurfic injections, is expected to challenge Roche's fast-growing CD20 target drug Ocrevus, which posted a staggering 57 percent increase in global sales in 2019 to a staggering 370.8 billion Swiss francs.
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, Novartic's portfolio includes Gilenya (fingolimod, S1P regulator), Mayzent (siponimod, next-generation S1P regulator), and Extavia (interferon β-1b for subsultural injections).
addition, Sanders sells Gatopa (Gratide acetate, 20mg/mL, 40mg/mL) in the United States, a generic of the Teva heavy MS drug Copaxone.
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