Merck Biopharma Korea said that the Ministry of Food and Drug Safety has granted sales approval for Mavenclad, its relapsing-remitting multiple sclerosis (MS) treatment, on Tuesday.
|Merck Biopharma Korea's relapsing-remitting multiple sclerosis treatment Mavenclad|
The ministry approved the treatment after the company confirmed the safety and efficacy through a phase 3 CLARITY trial, which included 1,326 patients with relapsing MS.
During the study period of 96 weeks, most of the patients -- 87 percent of patients treated with placebo, 91.9 percent of patients treated with 3.5 mg/kg Mavenclad, and 89 percent of patients treated with 5.25 mg/kg Mavenclad -- completed the treatment.
The primary endpoint was to confirm the treatment's efficacy on the disease's activities such as annual recurrence rate, risk of disability progression, and MRI active lesion.
The results showed that the annual recurrence rate of a patient's treatment with Mavenclad (3.5 mg/kg) was 57.6 percent lower than the placebo group. Mavenclad (3.5 mg/kg) also showed a 79.7 percent non-recurrence rate compared to 60.9 percent of the placebo group after 96 weeks of treatment.
Further analysis of 806 subjects enrolled in the CLARITY extension trial among patients who completed CLARITY clinical trials revealed that patients who received Mavenclad (3.5 mg/kg) for two years showed a reduced frequency of recurrence and delayed disability rate for up to four years after treatment.
The Mavenclad group also showed improved efficacy of inactive lesions on brain MRI for 96 weeks compared to placebo, and delayed the 3-month disability progression period measured by the expanded disability status scale, versus placebo.
The relative reduction rates of Mavenclad's T1 gadolinium-enhancing and T2 active lesions were 86 and 73 percent, respectively.
"Mavenclad demonstrates an innovative breakthrough that will provide a sustained effect over four years with only a short therapy period of 20 days," Merck Biopharma Korea General Manager Javed Alam said.
The company expects that the treatment will help solve the unmet medical need of domestic patients with MS and to improve their quality of life significantly, Alam added.
MS is a major cause of nontraumatic disorder that affects people in their 20s to 40s. It is a rare autoimmune disease that causes pain and paralysis in the central nervous system, such as the brain and spinal cord. Currently, the prevalence of multiple sclerosis in Korea is known to be 3.5 people out of 100,000.
Relapsing-remitting MS, which is the most common form of multiple sclerosis, can also cause disability if not treated properly.