Date:
December 28, 2020
Issue #:
1614
Summary:
The FDA has approved a subcutaneous formulation
of the recombinant human anti-CD20 antibody
ofatumumab (Kesimpta – Novartis) for treatment
of adults with relapsing forms of multiple sclerosis
(MS), including clinically isolated syndrome (initial
neurological episode), relapsing-remitting disease,
and active secondary progressive MS (SPMS).
Kesimpta is the second anti-CD20 antibody to be
approved for these indications; IV ocrelizumab
(Ocrevus), which is also approved for treatment
of primary progressive MS, was the first. An IV
formulation of ofatumumab (Arzerra) has been
available for treatment of chronic lymphocytic
leukemia (CLL) since 2010.
of the recombinant human anti-CD20 antibody
ofatumumab (Kesimpta – Novartis) for treatment
of adults with relapsing forms of multiple sclerosis
(MS), including clinically isolated syndrome (initial
neurological episode), relapsing-remitting disease,
and active secondary progressive MS (SPMS).
Kesimpta is the second anti-CD20 antibody to be
approved for these indications; IV ocrelizumab
(Ocrevus), which is also approved for treatment
of primary progressive MS, was the first. An IV
formulation of ofatumumab (Arzerra) has been
available for treatment of chronic lymphocytic
leukemia (CLL) since 2010.
