South Korea’s SK Chemicals Co. announced on Sunday its hemophilia A drug Afstyla has been approved in Australia, marking the first case of Korea’s novel biologic drug to be available in the U.S., Europe, Canada and Australia.

SK Chemicals signed a license deal for Afstyla with Australian pharmaceutical company CSL in 2009, allowing CSL to lead commercial development, global clinical trials and regulatory approval processes.

Unlike previous hemophilia drugs, Afstyla has a single polypeptide chain that provides long-lasting protection from bleeding with improved molecular safety. The new drug is used twice weekly versus three or four times per week administration of previous therapies.

Afstyla was approved by the U.S. Food and Drug Administration (FDA) last May, by Canadian health authorities last December and by European authorities early this year.

By Kim Hye-soon

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