US FDA approves injectable version of Roche's multiple sclerosis therapy (updated)

Halozyme Therapeutics

13/09/2024 19:33

(Adds price and availability in paragraph 4)
       Sept 13 (Reuters) - The U.S. Food and Drug
Administration on Friday approved Roche's  ROG.S  under-the-skin
injection to treat patients with multiple sclerosis.
    The subcutaneous or under-the-skin therapy called Ocrevus
Zunovo has the potential to expand treatment options to centers
unable to administer the IV version.
    The therapy is already approved as an IV infusion for
multiple sclerosis under the brand name Ocrevus, which is given
twice a year. The subcutaneous version is a 10-minute injection
also given twice a year.
    The company expects Ocrevus Zunovo to be available from
early October, with the annual list price at parity with Ocrevus
IV in the U.S.
    Ocrevus is used to treat patients with relapsing multiple
sclerosis (RMS) and primary progressive multiple sclerosis.
    Multiple sclerosis is a condition that occurs when the
immune system attacks the brain and spinal cord. The company
estimates that the disease affects more than 2.9 million people
worldwide.
    The approval was based on data from a late-stage study that
showed no significant difference in Ocrevus levels in the blood
when administered subcutaneously.
    The subcutaneous formulation, which received marketing
authorization from the European Commission in June, combines
Ocrevus with Halozyme Therapeutics'  HALO.O  drug delivery
technology, which allows the therapy to be rapidly dispersed and
absorbed into the bloodstream.
    Ocrevus is a monoclonal antibody designed to target
CD20-positive B cells, a specific type of immune cell thought to
be a key contributor to nerve cell damage.
    More than 350,000 people with multiple sclerosis have been
treated with Ocrevus IV globally, according to Roche. The IV
formulation of Ocrevus recorded sales of 6.38 billion Swiss
francs ($7.52 billion) in 2023.
    Other approved treatments for RMS include Novartis'  NOVN.S 
Kesimpta, given as a monthly injection, and Biogen's  BIIB.O 
Tysabri, administered as an IV infusion every four weeks.

($1 = 0.8481 Swiss francs)

 (Reporting by Sneha S K, Sruthi Narasimha Chari and Puyaan
Singh in Bengaluru; Editing by Shilpi Majumdar and Vijay
Kishore)
 ((mailto:Sneha.SK@thomsonreuters.com;))