Novartis' application for a single anti-anti-listing is to be included in the priority review for the treatment of multiple sclerosis

November 23, according to the CDE official website, Novarma CD20 single anti-ovtomu single anti-listing application (JXSS2000049) was included in the scope of the proposed priority review varieties, the formulation of adaptive for adult hairstyles Multiple sclerosis (RMS), including clinical isolation syndrome (CIS), relapsed remission-relieving multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS), means it is one step closer to the drug's domestic approval.
of Ofatumab, an all-human antibody developed by Genmab to target CD20-positive B cells, was granted to GSK in 2006.
October 2009, the drug was approved by the FDA for the first-line treatment of patients with chronic lymphoblastic leukemia (CLL) who had not previously been treated and were not suitable for fluorodalabin-based treatment, known as Arzerra.
subsequently, the drug was approved for prolonged treatment in patients with relapse or progressive CLL who received at least two lines of treatment and achieved full or partial remission, and for patients with combined fluorodalabin and cyclophosphamide for relapse CLL.
novart paid $1 billion from GSK in 2015 to obtain the right to operate Ofatomu monoant, and assigned it a new research and development code, OMB157, to develop as a new generation of B-cell depletors.
In August 2020, Afatomudan was approved by the FDA for the treatment of multiple sclerosis (RMS), including adult clinical isolation syndrome, relapse disorders, and active secondary inflammatory diseases, known as Kesimpta.
multiple sclerosis (MS) is a serious, lifelong, aggressive, disabling central nervous system demyelination disease, mainly manifested in muscle weakness, fatigue, pain, cognitive impairment and visual problems, has become the main cause of non-trauma disability.
the disease is good in 20-40 years of age, of which women account for about two-thirds, according to statistics around 20 million MS patients worldwide, more than 30,000 confirmed patients in China.
According to the course of the disease, MS can be divided into four types, namely relapse remission (RRMS, about 85%), secondary progression type (SPMS, about 80% of RRMS progression for SPMS), primary progression type (PPMS, about 10%), and progress re-hair (PRMS, about 5%).
different treatment decisions, the drugs currently approved are primarily for RRMS.
according to insight database, a variety of MS drugs have been approved in China, namely recombinant human interferon β-1a, recombinant human interferon β-1b, trafluamine (Sanofi), Fingomod (Novaral) and Sinimod (Novartic), where Teflon was approved for RMS, Fingomod for PRMS, and Sinimod for RMS (including CIS, RRMS and SPMS).
, both Teflon and Fingomod face the threat of generics, and both have submitted applications for generic drugs.
this time, Novarma's application for the listing of RMS for single anti-treatment was included in the proposed priority review by CDE, which is expected to accelerate its domestic approval and further increase Novarma's position in the MS market.
According to the 2019 sales revenue of MS drugs, Biogen, Roche and Novarma ranked in the top three, but with the expiration of patents, fumarate, fengomod, Teflon, etc. are facing the impact of generic drugs, the future MS market enterprise structure is not known.
for Novart, the market for Fingomod began to shrink, with sales falling from $3,341 million in 2018 to $3,223 million in 2019.
Sinimod's sales in 2019 were only $226 million due to late approval (FDA 2019/03; NMPA 2020/05).
with the approval of the Ovtomu monoantigen treatment of MS in the United States as well as domestic production, I believe that in the future, with the increase in the scope of approval, Novartic is expected to reverse the decline in the MS market, or even achieve beyond.
, it's worth noting that Kesimpta is the first B-cell-targeted therapy to allow patients to self-inject themselves at home once a month with Sensoready's auto-injection pen.
and its approved clinical trials ASCLEPIOS I and ASCLEPIOS II show that Kesimpta has an advantage in significantly reducing annual recurrence rate (ARR, primary endpoint), 3 months of confirmation of disability progression (CDP), enhancement (Gd plus) T1 and increasing the number of new or increased T2 lesions compared to Teflon, and is expected to be the preferred treatment for RMS patients.
, Kesimpta's registration approvals in other countries around the world are also being carried out simultaneously and are expected to be approved in Europe by Q2 2021.