Arzerra® / Kesimpta® (ofatumumab)

BL 125326

Arzerra® / Kesimpta® (ofatumumab)

BL 125326

U.S. License Holder:

Novartis

Date of License:

October-26-2009 / August-20-2020

Last Update:

Mar-08-2024

approved_indications FDA-Approved Indications


ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated:

In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate;

For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL;

For the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

KESIMPTA (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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