Kesimpta Approved to Treat Relapsing Multiple Sclerosis

August 20, 2020 – The U.S. FDA has approved Kesimpta® (ofatumumab), manufactured by Novartis, to treat adults who have relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Kesimpta is the first self- administered, targeted B-cell therapy for patients diagnosed with relapsing MS.

MS is a chronic disease of the central nervous system (CNS) that can develop at any age, but is typically diagnosed in adults who are between the ages of 20 and 50. Damage to the CNS interferes with the sending of signals from the brain to other parts of the body, which can lead to a wide range of symptoms – including muscle spasms, numbness and tingling, pain, difficulty walking, dizziness, and tremors. Many patients develop a relapsing form of MS, in which there are periods of disease stability or remission between periods of disease worsening (relapse).

In clinical studies, Kesimpta significantly reduced the annualized relapse rate, disability progression, and the number of T1 and T2 lesions (areas of damage to the CNS identified via MRI) compared to treatment with teriflunomide, a current standard of care. The drug may also halt new disease activity, with 87.8% of patients treated with Kesimpta showing no evidence of disease activity within the second year of treatment and 47% having no evidence of disease activity within the first year.

Recommended initial dosing is 20mg administered via subcutaneous injection at Weeks 0, 1, and 2 of treatment, followed by maintenance dosing of 20mg administered monthly starting at Week 4. A Hepatitis B virus and a quantitative serum immunoglobulins screening must be performed prior to the first dose.

Novartis has launched Kesimpta at a wholesale acquisition cost (WAC) of $6,916.67 per auto-injector.