April 20, 2024
Bio
SK Chemicals haemophilia drug set for EU approval
[THE INVESTOR] South Korea’s SK Chemicals said Nov. 15 that its haemophilia drug has been granted marketing authorization from a committee of the European Medicines Agency, paving the way for commercialization in the European Union.
 |
It normally takes one to two months to receive the final EMA approval after obtaining recommendation from the Committee for Medicinal Products for Human Use.
Afstyla is the first and only single-chain product for treating the rare bleeding disorder haemophilia A, developed by SK Chemical and licensed out to Australia‘s biotechnology firm CSL in 2009.
In May, the company won approval from the US Food and Drug Administration to sell the drug in the country. The product is awaiting approval in Switzerland and Australia.
The drug is specifically designed for protection from bleeding with two or three times weekly dosage and low unit consumption at both dosage regimens.
In clinical trials, Afstyla demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis, according to CSL.
By Park Han-na (hnpark@heraldcorp.com)
