Is Kesimpta approved in Europe?
Is Kesimpta approved in Europe?
Basel, March 30, 2021 — Novartis announced today that the European Commission has approved Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features.
When was ofatumumab approved for MS?
Kesimpta was approved in August 2020 for the treatment of adults with relapsing forms of MS.
Who makes ofatumumab?
FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis | Novartis.
How much is Kesimpta?
The cost for Kesimpta subcutaneous solution (20 mg/0.4 mL) is around $7,886 for a supply of 0.4 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
When was ocrelizumab approved by the FDA?
On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved OCREVUS (ocrelizumab) for treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. This represents the first product approved for primary progressive multiple sclerosis.
How effective is Ocrevus for MS?
Over the two years of the clinical trials, Ocrevus reduced the number of relapses by 50% compared to interferon beta 1a, reduced disability progression sustained for 3 and 6 months, and significantly reduced the number of lesions seen on MRI scans compared to beta interferon.
Is Kesimpta approved in Canada?
Kesimpta (ofatumumab) was approved by Health Canada for the treatment of adults with relapsing-remitting MS with active disease defined by clinical and imaging features.
Is Kesimpta new?
On August 20, 2020, Novartis announced that the United States Food and Drug Administration (FDA) approved Kesimpta® (ofatumumab) for adults with relapsing forms of multiple sclerosis (RMS), which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease.
What is the difference between ofatumumab and ocrelizumab?
We mentioned that ofatumumab is a medication that’s self-administered by patients. Ocrelizumab is a medication that’s administered to the patient. Sometimes that may be a relative advantage in certain populations, when I actually know the patient had the treatment.
How much does ofatumumab cost?
Table 8CADTH Cost Comparisons for Relapsing-Remitting Multiple Sclerosis
| Treatment | Strength | Annual cost ($) |
|---|---|---|
| Ofatumumab (Kesimpta) | 20 mg/0.4 mL | Year 1: 35,000d Year 2: 28,000 |
| Injectable therapies | ||
| Glatiramer acetate (Copaxone) | 20 mg/1 mL | 17,411 |
| Glatiramer acetate (Glatect) | 20 mg/1 mL | 11,826 |
When will ofatumumab be approved in the US and Europe?
Regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by Q2 2021
What is the safety profile of ofatumumab?
The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results 1,4. Additional secondary endpoints included confirmed disability improvement at six months, serum levels of neurofilament light chain (NfL), and rate of brain volume loss 2,3.
What is the generic name for ofatumumab?
Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a fully human monoclonal antibody to CD20, which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab…
Can ofatumumab be self-administered for multiple sclerosis?
The positive results of the study will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in Florida, US. These results show that ofatumumab offers a highly effective B-cell therapy that can be self-administered at home using a patient-friendly autoinjector pen.
