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August 17, 2018

LegoChem’s tuberculosis therapy gets FDA fast track status

PUBLISHED : February 13, 2018 - 13:08

UPDATED : February 13, 2018 - 17:43

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[THE INVESTOR] LegoChem Biosciences said on Feb. 12 it has received Fast Track designation from the US Food and Drug Administration for LCB01-0371, its next generation oxazolidinone antibiotic.

The drug candidate is currently in phase 2 trials for the treatment of multidrug-resistant tuberculosis. 




Fast Track designation is granted by the FDA to expedite the review and facilitate the development of drugs to treat serious conditions with significant unmet medical needs. The purpose of the process is to get new drugs to patients quicker.

Last year, LCB01-0371 was granted Qualified Infectious Disease Product designation, which is given to antibacterial products that treat serious or life-threatening infections, as well as Orphan Drug status, which provides incentives to companies developing drugs for rare diseases and conditions, from the US regulator.

The Korean company had entered an agreement with RMX Biopharma to grant Chinese development manufacturing and commercialization rights to LCB01-0371 in December 2016.

By Park Han-na (hnpark@heraldcorp.com)

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