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May 22, 2020

Roche reports additional safety data of satralizumab in NMOSD

Roche has reported new pooled safety data of its satralizumab drug to treat patients suffering from neuromyelitis optica spectrum disorder.

Roche has reported new pooled safety data of its satralizumab drug to treat patients suffering from neuromyelitis optica spectrum disorder.

According to the data, satralizumab was well-tolerated in wider patient population,  including adolescents, who lack approved treatments.

Satralizumab is an investigational humanised monoclonal antibody designed to target the interleukin-6 (IL-6) receptor, which is involved in the inflammation in NMOSD patients.

The drug is based on antibody recycling technology to enable a longer duration of antibody circulation and subcutaneous dosing every four weeks.

Pooled data from the double-blind portions of the SAkuraStar and SAkuraSky Phase III trials revealed comparable rates of adverse events (AE) and serious adverse events (SAEs) between satralizumab and placebo groups.

The most common AEs across the treatment groups were urinary tract infection and upper respiratory tract infection. Investigators did not report any deaths or anaphylactic reactions.

Roche added that the drug’s safety profile in the open-label extension (OLE) was consistent with the double-blind portion in terms of the nature and rate of AEs. The company reported no meaningful changes in incidence, rate, or type of infections.

A separate analysis of the SAkuraSky trial showed that the benefit-risk profile in adolescents on the same dosing and frequency was generally consistent with the adult population.

Great Ormond Street Children’s Hospital researcher Cheryl Hemingway said: “It is highly encouraging to see the positive results from the satralizumab trial in young people with NMOSD. There is no approved treatment option for this condition, and youngsters live day-to-day with the possibility of unpredictable, severe relapses that can cause life-long disability.

“The satralizumab studies represented a broad population, including adolescents, and we are hopeful for what this medicine could bring to young people living with this rare condition.”

NMOSD is a rare, debilitating autoimmune disease of the central nervous system that causes damage to the optic nerves and spinal cord, blindness, muscle weakness, and paralysis.

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