More about our cookie policy.
Novartis AG has received FDA approval for the anti-CD20 anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in recurrent sclerosis (MS) bureaucracy in adults, with a label that includes clinically remote syndrome and recurrent sender, as well as an active secondary progressive. Disease.
A targeted B-cell cure that has demonstrated astonishing efficacy with a protective profile similar to that of oral Aubagio (teriflunomide), Sanofi SA dihydroorotate dehydrogenase inhibitor, Kesimpta is a first-class remedy option for patients with recurrent MS, Basel, Switzerland, says Novartis. . It is also the first B-cell cure that can be self-administered once a month at home with an auto-injector pen.
Approval came earlier than expected, after which regulators reported a three-month delay from the date of the PDUFA, bringing the sBLA resolution to September. Ofatumumab was first approved in October 2009 as Arzerra for Chronic Lymphocytic Leukemia (CLL). Kesimpta’s clinical progression program lasted 10 years and affected more than 2,300 patients worldwide. In partnership with Genmab A/S in Copenhagen, Denmark, Kesimpta reaches a different dosing and management management regime than THE LLC with Arzerra.
Phase III studies on Asclepios I and II have strengthened the case of relapse of MS approval. These were twin experiments, identically designed, flexible (up to 30 months), double-blind, randomized and multicenter to measure the protection and efficacy of 20 mg per month subcutaneous injections compared to 14 mg Aubagio tablets taken once daily. There were 1,882 elderly patients aged 18 to 55, with an extended disability scale score of between 0 and 5.5 1.2. The studies were conducted at more than 350 sites in 37 countries. The main criterion to show that Kesimpta was impressive for Aubagio by reducing the frequency of relapses shown (as assessed through annualized rates) in treated patients for up to 30 months. Secondary assessment criteria included retention prior to the progression of the disability shown at 3 and six months, showed a change in disability at six months, T1 injuries expanded gadolinium, number of new or expanding T2 lesions, serum degrees of the neurystric chain, and brain rate. volume loss.
Soft green for Kesimpta applies not only to The Paris-based Aubagio of Sanofi, approved in September 2012, but also to Ocrevus (ocrelizumab), Roche Holding AG’s mobile anti-CD20 B treatment in Basel, Switzerland, and Biogen Inc, based in Cambridge, Massachusetts. ., approved for marketing in the U.S. in March 2017.
Piper Sandler analyst Christopher Raymond said in a June report on his company’s neurologist research that Kesimpta is “preparing as Ocrevus’s main rival.” The latest smart news for Novartis follows this month’s announcement that the U.S. District Court In Delaware, it has confirmed the validity of the Gilenya (fingolimod) dosing patent. Gilenya, a sphingosine 1-phosphate receptor modulator, approved in September 2010 for recurrent MS. The patent pitted Novartis against Hec Pharm Co. Ltd. de Guangdong, China.
Enjoy a long-term policy to get the most comprehensive view of the market with BioWorld, BioWorld MedTech and BioWorld Asia in an easily accessible subscription.