Eisai Parkinson’s disease drug Equifina listed and launched

A new MAO-8 inhibitor to be released after 8 years improves motor and non-motor symptoms

Eisai’s Parkinson’s disease treatment Equifina has been released to the South Korean market on Feb.

 

2 with the National Health Insurance (NHI) reimbursement.

 

The Ministry of Health and Welfare (MOHW) notice issued on Jan.

 

29 granted the NHI benefit on Equfina (safinamide) as an adjuvant treatment to levodopa for idiopathic Parkinson’s disease patients, as well as the nursing insurance reimbursement for using the drug within its approved label and general principles of anti-Parkinson’s disease treatment.

 

South Korea’s Ministry of Food and Drug Safety (MFDS) authorized the treatment on June 24, 2020, as a once-daily oral add-on therapy to levodopa for patients with Parkinson’s disease.

 

A new third-generation monoamine oxidase B (MAO-B) inhibitor, working dual mechanism on dopaminergic and non-dopaminergic neurotransmission, Equfina conducted a Phase III trial and demonstrated a significant efficacy in Parkinson’s disease patients with motor fluctuation.

 

Mostly, levodopa is used as a standard of care in Parkinson’s disease, but the drug has reportedly shown 75 percent risk of complications when used for over five years.

 

And apparently, Equfina, as an add-on to levodopa, increases the drug effect period that could wear off if administered for a long term.

 

A Phase III SETTLE study evaluated the efficacy and safety of Equifina in patients with Parkinson’s disease showing motor fluctuation symptoms, and confirmed the drug significantly improving the “on” time in patient group who have taken the drug for 24 weeks, compared to the placebo group.

 

Equifina has also proved to reduce the “off” time of levodopa, and shortened the “off” time of the other combined drug regardless of the drug type or severity of the motor fluctuation symptoms.

 

In the SETTLE study, the Parkinson’s Disease Questionnaire (PDQ-39) was given out to the participating patients to assess their quality of life, and the group administered with 50-100 mg per day showed changes of -3.17 from the baseline, which was an improved result compared to -0.68 in the placebo group.

 

Another Phase III trial, Study 016 also found statistically meaningful result of PDG-39 in Equifina-administered group (100 mg) compared to that of the placebo group.

 

Particularly in the mental wellbeing questionnaire, the Equifina group’s changes from the baseline to week 24 marked -5.14, which improved compared to the placebo group.

 

CEO Koh Hong-byung of Eisai Korea noted, “By releasing Equifina, I am happy to provide a new treatment option to Parkinson’s disease patients in South Korea, who were short of treatment options.

 

And as we launch the drug with the healthcare benefit, we hope to lessen the financial burden on those patients in South Korea.”