Published : Dec. 19, 2016 - 15:53
South Korean biopharma company SK Chemicals said Sunday that a hemophilia treatment it has co-developed with its partner CSL Ltd. has been approved for sale in Canada, marking another step forward in breaking into overseas markets.
Last week, Canada's drug regulator Health Canada granted marketing and sales approval for Afstyla, a biologic drug for hemophilia A, to CSL Behring, a subsidiary of CSL Ltd.
Afstyla was originally developed by SK Chemicals and licensed out to Australian biotech firm CSL Ltd. in 2009. Under the licensing deal, CSL has been carrying out Afstyla's overseas clinical trials and subsequent approval procedures.
Abstyla, or NB601 (SK Chemicals)
Canada is the second country to give the green light to Abstyla's sales after the US. The US Food and Drug Administration had approved the drug in May this year.
Afstyla, also known as NBP601, treats hemophilia A, a congenital blood disorder found mostly among males. Patients with hemophilia A experience prolonged or spontaneous bleeding as blood does not clot normally due to a missing or defective factor VIII, an essential blood-clotting protein.
Afstyla is the first and only “single-chain product” for hemophilia A that acts as a longer-acting substitute for the factor VIII protein. Patients can take Afstyla just twice a week, compared to three to four injections required by existing drugs.
Moreover, global clinical trials of Afstyla have shown that the new drug does not cause the formation of neutralizing antibodies -- the most serious side effect of existing hemophilia drugs, SK Chemicals said.
Afstyla is geared to obtain sales approval in Europe in the coming months, as the European Medicines Agency’s Committee for Medicinal Products for Human Use already adopted a positive recommendation of the drug in November.
In addition, the new hemophilia drug is undergoing independent reviews by drug regulators in Switzerland and Australia as well, SK Chemicals said.
“CSL expects Afstyla will become a strong competitor in the global market for Type A hemophilia treatments,” the Korean drugmaker said. “In turn, we expect to reap royalties from Afstyla’s global sales.”
By Sohn Ji-young (
jys@heraldcorp.com)