Sept 12 (Reuters) - The U.S. Food and Drug

Administration on Thursday approved Roche's

under-the-skin injection to treat patients with multiple

sclerosis.

The therapy is already approved as an infusion or IV therapy

for multiple sclerosis, which is given twice a year, under the

brand name Ocrevus.

The approval for the subcutaneous, or under-the-skin,

version of the therapy will help expand its use to treatment

centers not equipped to handle intravenous therapies.

Ocrevus is used to treat patients with relapsing multiple

sclerosis (RMS) and primary progressive multiple sclerosis

(PPMS).

Roche did not immediately respond to a Reuters' request

seeking details on availability date and pricing of the

injectable version.

Multiple sclerosis is a condition that occurs when the

immune system attacks the brain and spinal cord.

Roche estimates that this disease affects more than 2.8

million people worldwide.

RMS is characterized by episodes of new or worsening signs

or symptoms, followed by periods of recovery. PPMS causes

gradual worsening of neurological symptoms and disability

without relapses or remissions.

The subcutaneous version, Tecentriq Hybreza, is a 7-minute

injection given twice a year, the same schedule as the

previously approved intravenous infusion.

The approval was based on data from a late-stage study that

showed Ocrevus as an under-the-skin injection was non-inferior

to its intravenous version, as measured by blood levels over 12

weeks.

The injectable version also had a safety and efficacy

profile similar to the IV formulation in patients with RMS and

PPMS.

The subcutaneous formulation, which received marketing

authorization from the European Commission in June, combines

Ocrevus with Halozyme Therapeutics' ( HALO ) 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 ($7.54 billion) in 2023.

Other approved treatments for RMS include Novartis'

Kesimpta, which is given as an injection once a month, and

Biogen's Tysabri - an IV infusion given every four

weeks.

($1 = 0.8464 Swiss francs)

(Reporting by Sneha S K,Sruthi Narasimha Chari and Urvi Dugar

in Bengaluru; Editing by Shilpi Majumdar and Subhranshu Sahu)