JW Pharmaceutical said Tuesday that the Ministry of Food and Drug Safety has expanded indication for Hemlibra, a hemophilia treatment developed by Chugai Pharmaceutical, as a routine preventive therapy for non-antibody hemophilia A patients.
|Chugai Pharmaceutical's hemophilia treatment Hemlibra|
The expanded indication comes after the company received the go-ahead to market the treatment in Korea in January 2019.
Hemlibra is the only subcutaneous treatment approved for people with hemophilia A with or without factor VIII inhibitors. It is a first-in-class drug that uses dual-specific antibody technology that mimics the coagulation mechanism of Factor VIII, and binds to activated Factor XI and Factor X at the same time, the company said.
The new indication allows hospitals to use the drug on severe hemophilia A patients who do not have antibodies. Also, the ministry will allow usage and dosage from the existing once-weekly subcutaneous injection method to a more extended dosage interval at the discretion of the medical staff.
While all of the preventive therapies launched so far have had to be administered intravenously two or three times a week, the treatment has dramatically improved patient convenience as they can extend intervals from the current once a week to once every four weeks, JW Pharmaceutical said.
“We have made strenuous efforts to expand the indication of our treatment to improve the quality of life for people with hemophilia A,” a company official said. “Since most patients with hemophilia A do not have antibodies, we expect that more patients will benefit from this indication.”
Hemophilia A, also called factor VIII deficiency, is a genetic disorder caused by a lack of a clotting protein called factor VIII. The Korea Hemophilia Foundation said there were 1,889 hemophilia A patients in the nation as of 2018 with only 51, or 3 percent, of them having antibodies.
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