Is ofatumumab FDA approved?
Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting …
When was ofatumumab approved by the FDA?
Ofatumumab was first approved by the FDA in 2009 for the treatment of CLL as an intravenous infusion. In CLL, the anti-CD20 monoclonal antibody is marketed under the name Arzerra.
Is Ofatumumab an immunosuppressive?
However, ofatumumab has potent immunosuppressive activity and its use has been reported to be associated with cases of reactivation of inactive hepatitis B which can be severe and can result in fatality.
When was Ibrutinib approved by FDA for CLL?
On March 4, 2016, the US Food and Drug Administration (FDA) approved ibrutinib (Imbruvica; Pharmacyclics), an orally administered BTK inhibitor, for the first-line treatment of patients with CLL.
Is Kesimpta FDA approved?
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 ofatumumab used for?
Ofatumumab injection is used in combination with chlorambucil to treat a type of cancer of the white blood cells called chronic lymphocytic leukemia (CLL) in patients who have not received any treatments in the past.
Does Kesimpta make you immunocompromised?
While the US Food and Drug Administration (FDA) has not made any specific warnings for people on immunosuppressant therapies as it relates to COVID-19 at the time this website was published, KESIMPTA is an immunosuppressant and may contribute to a higher risk or severity of infections because of its suppressive effect …
Is Ibrutinib FDA approved?
NORTH CHICAGO, Ill., April 21, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of previously untreated patients with …
Is IMBRUVICA FDA approved?
(“Janssen”) today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA ® (ibrutinib) capsules as the first therapy indicated specifically for patients with Waldenström’s macroglobulinemia (WM), 1 a rare, indolent type of B-cell lymphoma.
When was Kesimpta FDA approved?
Development Timeline for Kesimpta
| Date | Article |
|---|---|
| Aug 20, 2020 | Approval FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis |
Can Kesimpta cause PML?
Progressive multifocal leukoencephalopathy (PML): PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks, and can result in death or severe disability.
Is ofatumumab a chemotherapy?
Ofatumumab is the generic name for the trade chemotherapy drug Arzerra. In some cases, health care professionals may use the trade name Arzerra when referring to the generic drug name Ofatumumab. Drug Type: Ofatumumab is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug.