The Ministry of Food and Drug Safety (MFDS) approved Teva-Handok’s injection treatment Cinquar (ingredient: reslizumab) to treat a severe type of asthma Monday, the company said.
Asthma is a chronic disease that causes inflammation in the lung airways and causes it to narrow, making it difficult to breathe. Severe asthma attacks can be serious and even life-threatening.
Cinqair is a humanized interleukin-5 antagonist monoclonal antibody used to treat a particular type of severe asthma. The drug reduces levels of blood eosinophils, a cell that contributes to asthma development, and thereby reduces the risk factors for asthma.
The drug will be used to treat the disease not adequately controlled in Korea, the company said.
The approval will allow Cinqair to be used as an additional maintenance therapy for eosinophilic phenotype asthma patients, indicated by those who have more than 400 cells/㎕ of blood eosinophilia before treatment, who did not respond well to other medications.
Two placebo-controlled clinical trials evaluated the drug’s efficacy and safety. The trials included asthma patients between 12 to 75 years old with blood count higher than 400/μL who did not respond to moderate or high dose ICS-based therapy.
The study found that Cinqair reduced the incidence of asthma exacerbations significantly in both studies. Two out of 477 patients taking Cinqair had anaphylaxis, the company noted. General adverse events were similar to the placebo group.
"We are delighted to be able to offer new treatment options to Korean asthma patients whose symptoms have not been controlled by conventional therapies through this approval," said Teva Handok CEO Park Sun-dong, "We expect the highly anticipated drug to substantially reduce the burden on patients with injections proved to have long-term effectiveness with an injection needed every four weeks."
The drug has win approvals to treat the disease in the U.S., Europe, and Canada with licensing underway worldwide, the company said.
Teva-Handok is a joint-venture business between the Israeli company Teva Pharmaceutical and Korean Handok Pharmaceutical, established in 2012.