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Shire’s hemophilia A treatment gains insurance coverage
  • By Lee Han-soo
  • Published 2018.09.03 14:35
  • Updated 2018.09.03 14:35
  • comments 0

Shire Korea said Monday that Adynovate, its long-lasting factor VIII gene recombinant hemophilia A treatment, began to receive insurance coverage from Saturday.

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 require patients to take the drug only twice a week. Standard injectable treatments for hemophilia A require three to four intravenous shots a week.

The company has also upgraded its device used for drug blending from Baxject II to Baxject III, which will improve the convenience of medication for domestic hemophilia A patients.

While Baxject II devices are made up of three components -- powder injections, injectable water, and mixing devices -- Baxject III will reduce the preparation time by introducing a one-step device that combines treatment and injectable water.

“The new device is expected to shorten the total drug administration time as well as the frequency,” the company said.

Domestic insurance price for Adynovate announced on July 1 is 675 won (60 cents) per 1IU. In a twice a week dosage, patients receive 20 to 25 IU in a single dose, while patients with severe hemophilia A symptoms receive up to 30 IU.

Adynovate proved its efficacy and safety through a multi-center, open-label, phase 2 and phase 3 trials conducted in more than 20 countries, including Korea, on 203 hemophilia A patients.

In clinical outcomes, the treatment showed preventative measures as the median annual bleeding frequency (ABR) was significantly lower in patients over 12 years of age with 1.9 cycles compared to 41.5 cycles for patients that received the treatment as an on-demand therapy. Nearly 40 percent of the patients who took the medication as a preventative measure also showed no single bleeding events.

Also, in 98 percent of patients, who switched from conventional factor VIII gene recombinant hemophilia A treatment to Adynovate, needed no change in their dose or treatment.

“With the introduction of the insurance coverage for Adynovate, a larger number of more domestic hemophilia A patients can now receive preventative treatment in a better therapeutic setting,” Shire Korea CEO Moon Hee-seok said. “We are also pleased to be able to provide a better treatment environment by launching Baxject III, which can drastically increase convenience for patients.”

corea022@docdocdoc.co.kr

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