Shire Korea, the local branch of the global biotech pharmaceutical Shire, said Thursday that the Ministry of Food and Drug Safety approved Adynovate, its long-lasting factor VIII gene recombinant hemophilia A treatment.
“Shire Korea is a global biotechnology pharmaceutical company that has been leading the development of rare blood disease drugs, and will continue to strive to expand treatment options for people with hemophilia A in Korea,” CEO Moon Hee-seok said.
Adynovate [Antihemophilic Factor(Recombinant), PEGylated] is an injectable therapy that has the same ingredient as Shire’s Advate, which is the country’s most commonly used hemophilia A treatment, according to the company.
“Adynovate is an innovative treatment that improves patient convenience by reducing the dosage to twice a week while maintaining the efficacy and safety of Advate,” CEO Moon said.
The newly approved injectable therapy touts improvements over Advate in the form of an extended half-life and fewer injections. Standard injectable treatments for hemophilia A require three to four intravenous shots a week.
The ministry’s approval is based on Adynovate’s multi-center, open-label, phase 2 and phase 3 trials conducted in more than 20 countries, including Korea, the company said. Studies showed that patients who got injected with Adynovate twice a week had a 95 percent reduction in overall annual bleeding rate (ABR) as opposed to those who used the treatment only upon bleeding or surgery. Around 40 percent of patients who used Adynovate for routine preventive therapy also did not experience bleeding, the company said.
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 estimated more than 1,600 hemophilia A patients in Korea in 2016.
Although there is no cure for the disorder, routine preventive therapy using Factor VIII genetic recombinant therapy has been used to reduce the frequency of bleeding, thereby preventing fatal bleeding and managing the disease, Shire said.
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