The US FDA accepted the New Drug Application (NDA) for Tedizolid, Dong-A ST’s super-bacteria antibiotic

-FDA accepted the NDA on Dec. 30, 2013 and designated June 20, 2014 as its review completion date
-Tedizolid expected to be approved for sale in Europe and Canada in the first half of 2014

Dong-A ST expects to be able to launch its new product Tedizolid, a super antibiotic designed to treat acute skin infections, in the US markets in the second half of 2014.

On January 2, 2014, Dong-A ST (President Park Chan-il) announced that the U.S.A.’s FDA had accepted the New Drug Application (NDA) for its antibiotic tedizolid phosphate, a super-bacteria antibiotic, which the company outlicensed to Trius Therapeutics (currently Cubist) of the United States back in January 2007.

As a rule, the FDA reviews an NDA for 60 days as a primary evaluation and, if it finds an application unsatisfactory, returns it within the period. Otherwise, it assigns a review completion date and begins the evaluation process. After submittal of the NDA for Tedizolid to the FDA in October 2013, the FDA announced its acceptance of the application documentation on December 20, 2013 and designated June 20, 2014 as the last date of its full-fledged review of the NDA.

Tedizolid is an oxazolidinone developed for both intravenous and oral administration for the treatment of acute bacterial skin and skin-structure infections (ABSSSI). At the beginning of 2013 it was designated by the FDA as a QIDP (Qualified Infectious Disease Product) eligible for faster approval and priority reviews with regard to ABSSSI and hospital-acquired and ventilator-associated bacterial pneumonia. As a result, the NDA review period has been shortened from twelve to six months.

“In view of the passage of the preliminary NDA review and the designation of the review completion date before the end of June, we expect to be able to launch Tedizolid in the US market in 2014,” said company president Park Chan-il. “When marketed in the US, Tedizolid is expected to strongly appeal to the country’s consumers due to its excellent tolerance, convenience of use (daily administration), and shortened treatment period. Therefore, Tedizolid will provide great relief to U.S. patients in terms of both convenience and finances.” He went on to say, “The product will also play a positive role in helping Dong-A ST take a big step forward in its efforts to evolve into a genuinely global pharmaceutical company.”

Meanwhile, the phase 3 clinical trials for Tedizolid were to meet the registration requirements of both the United States and Europe - as outlined in the guidelines of the FDA and the EMA (European Medicines Agency) ？ which are designed to evaluate the efficacy of antibiotics. Cubist plans to submit a Marketing Authorization Application (MAA) to both Europe (EMA) and Canada during the first half of 2014.

In 2011, Trius (currently, Cubist) sublicensed its rights to develop and market Tedizolid for Asia and other emerging countries to Bayer. Therefore, Bayer will market the product in Asia, including China and Japan, and other emerging markets around the world once the clinical trials have been completed and the necessary approvals have been obtained, whereas Dong-A ST, the originator of the medicine, will market it in Korea. Tedizolid will soon be made available around the world.