Send me real-time posts from this site at my email
Motley Fool

U.S. and EU Regulators Reviewing Novartis' Leukemia Drug for Expanded Approval in Multiple Sclerosis

Drug regulators in the U.S. and EU have accepted Novartis' (NYSE: NVS) applications to expand their approvals of ofatumumab to include patients with multiple sclerosis. The Food and Drug Administration is giving the marketing application a priority review, so a decision should come by this June. The European Medicines Agency is expected to make its decision by the second quarter of 2021.

Shareholders in Genmab (NASDAQ: GMAB), which licensed ofatumumab to Novartis in 2015, will also want to be watching for the results of these applications since Genmab will receive a 10% royalty on sales of the drug for patients with multiple sclerosis.

Ofatumumab is the active ingredient in Novartis' Arzerra, which is approved to treat chronic lymphocytic leukemia. The drug works for both leukemia and multiple sclerosis because both diseases involve the immune system, which ofatumumab inhibits through its targeting of CD20 positive B-cells.

Image source: Getty Images.

The application is based on two phase 3 studies, dubbed Asclepios I and II, where the pharmaceutical company showed ofatumumab reduced the annualized relapse rate by 50.5% and 58.5%, respectively, compared to Sanofi's (NASDAQ: SNY) Aubagio. Ofatumumab also suppressed the lesions associated with multiple sclerosis and reduced the risk of disability progression.

Arzerra is infused in patients with leukemia, but for multiple sclerosis, the drug can be administered by patients through a subcutaneous injection. To make it even easier on patients, Novartis has developed an autoinjector pen, which it has shown is equivalent to the pre-filled syringes used in the Asclepios studies.

10 stocks we like better than Novartis
When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*

David and Tom just revealed what they believe are the ten best stocks for investors to buy right now... and Novartis wasn't one of them! That's right -- they think these 10 stocks are even better buys.

See the 10 stocks

*Stock Advisor returns as of December 1, 2019

Brian Orelli and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.


Source

Popular posts

Welcome!!! Is it your First time here?

What are you looking for? Select your points of interest to improve your first-time experience:

Apply & Continue