Shire Korea, the local branch of the global biotech pharmaceutical Shire, held a symposium on Monday celebrating the launch of Adynovate, its long-lasting factor VIII gene recombinant hemophilia A treatment.
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 more than 1,600 hemophilia A patients in the nation as of 2016.
Adynovate is an injectable therapy that has the same ingredient as Shire’s Advate, the most commonly used hemophilia A treatment here. The medication touts improvements over Advate in the form of an extended half-life and fewer injections that only require patients to take the drug twice a week. Standard injectable treatments for hemophilia A require three to four intravenous shots a week.
The half-life extension of Adynovate is due to the company’s PEGylation technique. The company selected the PEGylation technology as it maintains the integrity of the parent molecule (Advate) and reduces the time at which the body clears Adynovate, resulting in an extended circulating half-life. The technology has allowed patients to reduce the number of doses per week.
“Adynovate has extended its half-life and blood residence times by 1.4 to 1.5 times in pharmacokinetics profiles (PK) compared to Advate, while also maintaining the efficacy and safety of existing adverse reactions,” Professor Guy Young, one of the speakers at the symposium, said. “PK test is an integral part of selecting patients to receive Adynovate.”
Based on the test, medical professionals need to administer the drug according to the patient's PK value and lifestyle, Young added.
Professor Park Young-sil of the department of pediatrics at Kyunghee University Hospital in Gangdong also made a presentation on Adynovate effect on Koreans.
“Twenty countries participated in a global clinical trial of Adynovate, including Korea,” Professor Park said. “Korean patients showed significant efficacy and safety in line with global data.” Adynovate also showed clinical efficacy and safety in the real-world as well as clinical outcomes, she added.
Shire Korea also expressed its confidence in its new treatment.
“It is an honor to introduce Adynovate 10 years after the launch of Advate in 2008,” Shire Korea CEO Moon Hee-seok said. “The company will continue to strive to expand treatment options for Koreans with hemophilia A.”