Hanmi Pharmaceutical said Wednesday that the company recently won the approval of the Ministry of Food and Drug Safety for its first combination drug to treat patients who have both asthma and allergic rhinitis.
Hanmi한미약품’s Monterizine몬테리진 is the combination of Montelukast (10g), a component that alleviates asthma and rhinitis symptoms by inhibiting leukotriene substances, and Levocetirizine HCI (5mg), an antihistamine used in the treatment of allergic rhinitis.
|Hanmi Pharmaceutical has won the approval for first combination drug to treat patients suffering from asthma and rhinitis.|
In Phase 3 clinical trials of 210 patients in 22 hospitals, the researchers compared monotherapy and Monterizine groups for four weeks. Clinical results showed that Monterizine was superior in the Mean Daytime Nasal Symptom Score (MDNSS) in the last two weeks compared with the single-dose group, Hanmi said in a press release.
It is the world’s first combination drug that showed its efficacy through Phase 3 clinical trials.
“Most of the asthma patients have allergic rhinitis symptoms, so we expect that Monterizine will be a necessary treatment for both medical staff and patients,” said a company official. “Hanmi Pharmaceutical will continue to launch differentiated medicines to provide more options for physicians and patients.
<© Korea Biomedical Review, All rights reserved.>