Roche's Approved Multiple Sclerosis Drug: Subcutaneous Injection At Par With Intravenous Infusion

Roche Holdings AG's RHHBY Phase 3 OCARINA II trial evaluating Ocrevus (ocrelizumab) as a twice-a-year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis or primary progressive multiple sclerosis (RMS or PPMS). 

Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks. 

Ocrevus subcutaneous injection was also comparable with Ocrevus IV in controlling the brain's magnetic resonance imaging (MRI) lesion activity over 12 weeks. 

The safety profile of Ocrevus subcutaneous injection was consistent with that of Ocrevus IV. 

The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics Inc's HALO Enhanze drug delivery technology.

Ocrevus IV is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active or relapsing secondary progressive MS [SPMS], in addition to the clinically isolated syndrome in the U.S.) and PPMS. 

Ocrevus IV is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions two weeks apart. Subsequent doses are given as single 600 mg infusions.

The company says Ocrevus twice a year 10-minute injection can further improve the treatment experience and expand Ocrevus usage in MS centers with IV capacity limitations or without IV infrastructure.

Ocrevus remains the first and only therapy approved for RMS and PPMS, and more than 300,000 people have been treated globally.