SK Chemicals received the sales approval for Skyzoster, a shingles vaccine, from the Ministry of Food and Drug Safety Monday, the company said. Skyzoster has become the second vaccine to be approved for the treatment of shingles worldwide, following Merck’s Zostavax.
Shingles, also known as herpes zoster, is a viral disease and the outcome of a reactivation of varicella-zoster virus and causes a painful skin rash with blisters on parts of the body. Symptoms include local pain in the area with some experiencing nerve pain. The disease can also cause chicken pox or vision loss.
SK Chemicals SK케미칼 conducted clinical trials to confirm the efficacy and safety to 842 patients aged 50 or older at eight clinical institutions, including Korea University Guro Hospital 고려대학교구로병원 and proved the non-inferiority of the products.
The treatment is an inactivated vaccine, consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed, reducing infectivity making it safer than live attenuated vaccines.
“In addition to Skycellflu4, the world's first quadrivalent cell culture flu vaccine, Skyzoster is the second world-class vaccine born by domestic technology,” said Park Mahn-hoon 박만훈, CEO of SK Chemicals. “We will further develop various premium vaccines to establish a market share in the vaccine market.”
Korea’s shingles vaccine market is estimated to be about 80 billion won ($69.78 million), compared with the global market of $683 million, last year, according to a study published by Datamonitor.
“We are planning to apply for the U.S. Food and Drug Administration’s approval,” said a company official.