On June 22, Dong-A ST announced that its new drug Sivextro (tedizolid phosphate) was recently approved by the U.S. Food and Drug Administration (FDA) after 11 years of development. This is the second drug developed in South Korea to be approved by the U.S. FDA after 2003 with LG Life Sciences’ “Factive.”
Sivextro is an oxazolidinone antibiotic which was developed in oral and injectable drug forms to treat acute bacterial skin and soft tissue infections (ABSSSI) from gram-positive bacteria including meta-cylinder-resistant Staphylococcus aureus (MRSA).
Dong-A ST received funding for pre-clinical studies as a part of its R&D projects for the Department of Health and Human Services, and finished them in 2006. In Jan. 2007, Dong-A ST entered a global licensing agreement with U.S.-based Trius Therapeutics and proceeded with clinical development in the U.S. and other countries.
Last year, the FDA gave Sivextro priority in evaluation and approval for treating ABSSSI, hospital-acquired pneumonia, and ventilator-associated pneumonia. The FDA’s Antibiotic Drug Advisory Committee (ADAC) unanimously upheld the permit this March. Last December, Sivextro passed the FDA’s preliminary examination, and it took only six months to be approved.
The European Medicines Agency (EMA) also completed a preliminary examination for sales approval this February, and the evaluation is expected to be completed in 2015. Since the EMA is conducting three worldwide clinical tests on the effectiveness of the drug not only for treating ABSSSI but also hospital-acquired pneumonia and ventilator-associated pneumonia, the treatment range for the drug may expand.
Every year, 80,000 people in the U.S. are infected with MRSA, and more than 11,000 die from it. According to GlobalData, a market research firm in the UK, the MRSA market in 2011 was estimated at about 2.7 trillion won (US$2.66 billion). In 2019, the market is expected to grow to about 3.5 trillion won (US$3.45 billion).
Cubist Pharmaceuticals will be selling Sivextro in the U.S., Canada, and Europe. The company is best known as the seller of Cubicin, 2013’s best-selling antibiotic in the U.S.
CEO Pak Chan-il said, “With the approval of the U.S. FDA, our antibiotic Sivextro is about to be released in the US this year,” and, “With its superior tolerability, one pill per day dosage, and shorter days of treatment, patients will soon prefer this antibiotic for it’s convenience and price.”