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Photo courtesy of Yonhap News |
[Alpha Biz= Paul Lee] Daewoong Pharmaceutical has received a one-month suspension of clinical trial activities from South Korea’s drug regulator for violating clinical trial compliance requirements.
According to the Ministry of Food and Drug Safety (MFDS) on February 4, Daewoong Pharmaceutical conducted a clinical trial without obtaining prior approval for changes to the trial plan, in violation of the Pharmaceutical Affairs Act and the Regulations on the Safety of Drugs and Related Products.
Under Korean regulations, sponsors are required to report and receive approval in advance from the MFDS when there are changes to the manufacturing or packaging sites of investigational medicinal products. Daewoong Pharmaceutical failed to notify the regulator of such changes.
The administrative penalty applies to a multicenter, randomized, placebo-controlled clinical trial evaluating the efficacy and safety of DWP16001 as an add-on therapy to insulin, with or without concomitant antihyperglycemic agents, in patients with type 2 diabetes.
The trial is part of Daewoong Pharmaceutical’s efforts to expand the indications for its diabetes treatment Enblo (generic name: inavogliflozin). DWP16001 is an SGLT-2 inhibitor–based therapy developed by the company for the treatment of type 2 diabetes and was launched in 2023.
Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)
