New multiple sclerosis drug Ocrevus is approved in Korea

“offers a new treatment option”

Ocrevus can be used to treat relapsing-primary progressive multiple sclerosis

Reduces annualized relapse rate and risk disability progression..." improves patients’ quality of life."

Dr.

 

Ho Jin Kim, Professor of Neurology, the National Cancer Center

A new drug for multiple sclerosis (MS), an intractable disease characterized by a high relapse rate, has been introduced to the market.

 

Roche's Ocrevus was approved in Korea for the treatment of relapsing-remitting MS as well as primary progressive MS, for which there had been no treatment options available.

 

Medical experts have expressed the importance of starting treatment with a high-potency agent early in the disease to prevent relapses.

 

On the 18th, Roche Korea held a press conference at the Lotte Hotel in Jung-gu, Seoul, to celebrate the approval of Ocrevus (ocrelizumab) as a treatment for multiple sclerosis in Korea.

 

Ocrevus was approved in Korea on March 13 as an autoimmune disease treatment that targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients.

 

With the approval, Ocrevus is available for the treatment of Relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, and primary progressive MS, in adults.

 

MS is a chronic disease in which myelin sheaths are damaged by an autoimmune inflammatory response.

 

Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic neurological disability.

 

As of 2022, an estimated 2,674 people in Korea are living with MS, with more than 62% of them in the 20-40 age group.

 

Until now, antibody drugs such as Tysabri (natalizumab), Gilenya (fingolimod), and MabThera (rituximab) were used for the disease, but there had been a steady need for additional high-potency drugs.

 

Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea.

 

Ocrevus also offers greater dosing convenience over Kesimpta (administered once a month), as it can be administered every 6 months.

 

The approval was based on the Phase III OPERA-I and II trials.

 

The trials evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (peginterferon beta-1a) in patients with relapsing-remitting MS.

 

In the trials, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy.

 

Specifically, in the OPERA I trial, the ARR was 0.156 in the 96-week Ocrevus arm and 0.292 in the control arm, and in the OPERA II trial, the ARR was 0.155 in the 96-week Ocrevus arm and 0.290 in the control arm.

 

Ocrevus also showed efficacy in the Phase III ORATIORIO trial that studied patients with primary progressive MS.

 

In this study, Ocrevus reduced confirmed disability progression (CDP) by 24% over 12 weeks compared to the control arm.

 

In terms of safety, the most common adverse events were infusion-related reactions (IRRs) and upper respiratory tract infections, most of which were mild to moderate in severity.

 

Dr.

 

Ho Jin Kim, Professor of Neurology at the National Cancer Center, said, "The unmet need for MS treatments remains high.

 

In Korea, there is no opportunity to use high-potency drugs in the treatment of MS, and we have low access to such drugs.

 

Overseas, high-potency drugs have been used as first-line treatment for MS since 2020.

 

Ocrevus was approved overseas in 2017, but it took 7 years for it to be approved in Korea." He added, “In MS, even the smallest differences in its early stages can have enormous cumulative effects.

 

This is why there are significant benefits to having early access to highly effective treatments.

 

These treatments will not only improve the quality of life for the patients but will also help reduce socioeconomic burden.

 

Ocrevus will be well utilized because it owns ample data on its efficacy as well as on long-term administration.”