Monday, January 25, 2021
Home Latest Pharma-News Novartis provides an update on FDA review of ofatumumab for relapsing multiple...

Novartis provides an update on FDA review of ofatumumab for relapsing multiple sclerosis

June 02, 2020: “Novartis announced that it has received notice from the US FDA that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis.

Regulatory action is now expected in September 2020.

“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals.

- Advertisement -

“We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.”

Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.

Related News: Novartis announces new late-breaking ofatumumab data at EAN

Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Ofatumumab
Ofatumumab (OMB 157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously.

As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion.

The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed and may preserve the B-cells in the spleen, as shown in preclinical studies.

Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility.

Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015.”
https://www.novartis.com/news/media-releases/novartis-provides-update-fda-review-ofatumumab-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis.

LEAVE A REPLY

Please enter your comment!
Please enter your name here

five + nine =

Most Popular

What is the process for Submission of Synopsis?

1.1 a. "Prior to submission of a thesis synopsis, a comprehensive assessment of the research work should be carried out by a...

COVAX Announces new agreement, plans for first deliveries

January 22, 2021: COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income...

FDA Approves OPDIVO® with CABOMETYX® as First-line Treatment for advanced Renal Cell Carcinoma

22 Jan 2021:  Bristol Myers Squibb announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks...

FDA granted approval of Cabenuva and Vocabria to ViiV Healthcare for HIV

January 21, 2021: "The U.S. FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human...