New drug for multiple sclerosis! Novartis ofatumab is under review in the US and Europe, the first B-cell therapy that can be injected subcutaneously once a month at home!

February 25, 2020 / BIOON / -- Novartis, a Swiss pharmaceutical giant, recently announced that the US Food and Drug Administration (FDA) and the European Drug Administration (EMA) have respectively accepted the application for biological product license (BLA) and marketing authorization (MAA) of the antibody drug ofatumumab for the treatment of adult patients with recurrent multiple sclerosis (RMS) Ofatumumab is a new type of B-cell therapy, which has long-term efficacy and good safety If approved, ofatumab has the potential to become the first treatment of choice for a wide range of RMS patient groups and the first B-cell therapy that can be easily administered and managed at home (with a monthly hypodermic injection using an automated syringe pen) Ofatumumab is expected to be approved in the US in June 2020 and in Europe in the second quarter of 2020 Novartis is committed to bringing ofatumumab to patients around the world, and regulatory applications are underway in other countries Ofatumumab's regulatory applications are based on positive data from two phase III clinical studies (0asclepios I, II) These two studies are head to head (H2H) studies They were carried out in patients with multiple sclerosis (RMS) The efficacy and safety of 20mg dose of ofatumumab subcutaneously injected once a month and 14mg tablet of teriflunomide orally taken once a day were evaluated Aubagio is one of Sanofi's oral multiple sclerosis drugs, and also the industry-leading MS oral disease correction drug The results of the two studies were presented at the 35th session of the European Committee for the treatment and research of multiple sclerosis (ECTRIMS), Stockholm, Sweden, in September 2019 The results showed that the two studies all reached the main end point Using the annual recurrence rate (ARR) evaluation, compared with aubagio, ofatumab showed a highly significant and clinically significant reduction in the number of confirmed relapses The specific data were as follows: in the two studies, the ARR in aubagio treatment group was 0.22 and 0.25, respectively; in the ofatumab treatment group, the ARR was 0.11 and 0.10, respectively; the ARR was relatively reduced by 50.5% and 58.8% (two studies) All of them were p < 0.001) Compared with aubagio, ofatumab showed a highly significant inhibition on gadolinium enhanced T1 lesions and new or expanded T2 lesions, showing a deep inhibition on new inflammatory activity In addition, the two studies also reached the key secondary end point of delay in identifying the progression of disability (CDP) The specific data were: in a pre-determined summary analysis, compared with aubagio, ofatumab reduced the relative risk of CDP at three months by 34.4% (P = 0.002) and the relative risk of CDP at six months by 32.5% (P = 0.012) In general, ofatumab has sustained efficacy and good safety The safety of ofatumab observed in two studies was consistent with the observation from phase II study In addition, Novartis completed the Apios study, an open label phase II study in RMS patients, to determine the bioequivalence of ofatumumab by subcutaneous injection via a pre filled syringe (used in the classios I and II studies) and an automated syringe pen (used in rms5 patients) The positive results of this study will be published at the forum of the American Committee for the treatment and research of multiple sclerosis (actrims) in Florida, USA These results show that ofatumab can provide a highly effective B-cell therapy, which can be used at home for self medication with patient-friendly automatic syringe pen "We are pleased that ofatumab has the potential to be the treatment of choice for patients and doctors seeking effective interventions," said Krishnan Ramanathan, global program director for Neuroscience at Novartis Ofatumab has shown high efficacy and good safety in RMS patients, and the drug is expected to provide the first B-cell therapy that can be administered at home We are firmly committed to reshaping treatment for patients across the MS spectrum and work closely with regulators to ensure that medicines are available to MS patients as soon as possible " Ofatumumab is an all human anti-CD20 monoclonal antibody, which plays a role by binding CD20 molecules on the surface of B cells and inducing effective B cell lysis and depletion Previously, ofatumab has been approved for the treatment of chronic lymphocytic leukemia (CLL) and sold under the brand name Arzerra But Novartis A new R & D code omb157 has been designated for ofatumab, which has been developed as a new generation of B-cell depletion agent The drug has a faster B-cell depletion effect and the potential favorable safety characteristics of retaining immunity At the same time, it has the convenience of subcutaneous injection once a month for self-administration, which is expected to challenge Roche's fast-growing CD20 targeted drug ocrevizumab, the latter 2019 Global sales increased by 57% to a staggering CHF 3.708 billion The positive results of phase IIB in patients with multiple sclerosis (MS) treated with ofatumumab (omb157) were published in 2014, which showed that the number of new brain injuries decreased significantly in the first 24 weeks after administration In December 2015, Novartis obtained all indications of ofatumab from genmab, including Ms In August 2016, Novartis launched the phase III project of ofatumumab in the treatment of recurrent multiple sclerosis (RMS) Novartis MS product portfolio multiple sclerosis (MS) damages the normal functions of brain, optic nerve and spinal cord through inflammation and tissue injury, affecting about 2.3 million people worldwide The disease is usually divided into three types: recurrent remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), and primary progressive multiple sclerosis (PPMS) About 85% of the patients initially developed multiple sclerosis of recurrence type In this field, Novartis product portfolio includes: gilenya (fingolimod, S1P regulator), mayzent (siponimod, a new generation of S1P regulator), and extravia (interferon β - 1B for subcutaneous injection) In addition, Sandoz sells glatopa in the United States, which is a generic of Copaxone, a MS drug with TIWA weight Source: Novartis announcements FDA and EMA filling acceptance of ofatumab, a level B-cell therapy for patients with relapsing forms of multiple sciences (RMS)