Domestic industry executives are watching closely when the regulator will release the result of their review of Envlo Tab. (ingredient: enavogliflozin, development name: DWP16001), a new diabetes treatment drug under development by Daewoong Pharmaceutical.
The Ministry of Food and Drug Safety published its “Global Innovative products on Fast Track (GIFT)” report last Tuesday.
According to this report, the domestic product name of the enavogliflozin, an SGLT-2 inhibitor diabetes treatment candidate, under development by Daewoong has been confirmed as the Envlo Tab.
The ministry said that Daewoong Pharmaceutical has been requested to supplement the data for the review and approval of the Envlo Tab. Daewoong applied for its approval to the ministry this past April.
“We have made the first request to supplement the primary data, and have not yet received the data from the company,” a ministry official said.
Envlo Tab. was designated as a target of the GIFT program by the food and drug safety ministry in October 2020. It was because the drug was being developed by one of the “innovative pharmaceutical companies" designated by the Ministry of Health and Welfare, one of the conditions for the selection. It was also the first substance designated under the GIFT program since it was introduced in 2020.
Owing to the designation, Daewoong will be notified of Envlo Tab.’s evaluation result within 90 business days, shorter than the existing approval review period of 120 business days.
However, the period for submitting the corresponding data after requesting the supplementary data from the ministry is not included in the 90 business days. If Daewoong submits supplementary data, the notification date of the approval results will become nearer.
In addition, the food and drug safety ministry can make two requests for additional data during the review period. The first request should be made within 60 business days, and the second request, within 10 business days. However, if a company requests to prolong the period, the ministry can accept it.
“There are many variables, so it's hard to tell when the results will come out,” the ministry official said.
Earlier, Daewoong revealed its plan to obtain domestic approval in the second half of this year and release enavogliflozin monotherapy and combination therapy in the first half of next year. It is also seeking to advance to overseas markets. For instance, the company won the nod for a phase 3 clinical trial of enavogliflozin’s single-dose administration in China this past February.
Industry watchers are paying close attention to whether Envlo Tab, Korea’s first SGLT 2-inhibitor diabetes treatment, can take the title of the “36th made-in-Korea new drug” following SK Bioscience’s Covid-19 vaccine, SKYCovione Inj.