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news.The Korean Ministry of Food and Drug Safety (MFDS) has granted approval for South Korean biopharmaceutical firm CrystalGenomics' first, tissue-specific once-a-day drug Acelex (polmacoxib) to treat osteoarthritis.
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Acelex has a new mode of action that specifically targets affected joints to relieve pain and restore mobility, while simultaneously preserving the integrity and safety of the gastrointestinal and cardiovascular systems.
The company said that pre-commercialization will start immediately and a commercial launch partner for the Korean market will be announced very shortly.
The approval is based on results from the Phase III trial, which suggest that Acelex 2mg once-a-day provides more rapid onset of relief from the signs and symptoms of osteoarthritis in comparison to celecoxib 200mg once-a-day, without added safety risk.
CrystalGenomics chairman and CEO Dr Joong Myung Cho said: "Today’s approval is a pivotal milestone for our company and shows the strength of our science and innovation, and our belief in helping patients in need."
According to the company, Acelex is expected to rapidly capture at least 10% of the arthritis market in South Korea that is estimated to be worth more than KRW500bn ($454m) per year as of 2013.