‘Policy support enabled the prompt approval of Envlo’

MFDS introduces Envlo’s case in the recently published book of medical product commercialization success casebook

Envlo is being reviewed for approval in 12 countries, including Mexico, Saudi Arabia, and the Philippines

The backstory of Daewoong Pharmaceutical's Envlo 0.3mg (enavogliflozin), which is a representative success case of the MFDS’s expedited review process, was introduced recently.

 

The government’s policy support for the commercialization of innovative products was what enabled Envlo’s clinical trial to approval in just 5 years.

 

In general, diabetes drugs that require long-term use take an average of 7 years from clinical trials to approval.

 

However, with MFDS support and Daewoong Pharmaceutical's R&D capabilities, Envlo succeeded in shortening this period to 5 years.

 

The MFDS published the 'Successful Medical Product Commercialization Casebook' and revealed not only Envlo, but also cases such as Roche Korea’s Lunsumio Inj (mosunetuzumab) and Recordati Korea's Qarziba  Inj 4.5mg/ml (dinutuximab beta).

 

Envlo Tab= Envlo Tab, the first product to be subject to expedited review, received a quality review in advance through a rolling review process prior to its approval.

 

During the approval review process, the company was able to closely communicate with the reviewer about the submitted data through product briefings and supplementary briefings, and the MFDS ordered data preparation guidance and requested supplementary material in real-time.

 

While the average time to the approval of a new drug in Korea is 314 days, Envlo was approved in 243 days, reducing the time required by 71 days.

 

Based on this, Daewoong Pharmaceutical licensed out Envlo’s technology for KRW 108.2 billion to Mexico and Brazil in February last year and for KRW 77.1 billion to Russia/CIS in December of the same year.

 

The company is currently undergoing approval reviews in 12 countries, including Mexico, Saudi Arabia, and the Philippines.

 

The MFDS said, “The rapid approval achieved by the collaboration of public and private sectors is expected to lead to the overall growth of the domestic pharmaceutical industry in the long run.

 

The expedited review of Envlo was an opportunity to experience the MFDS’s determination to support domestically developed new drugs.” “After being designated as the first drug subject to expedited review, we communicated with the reviewers frequently through briefings and technical consultations, which helped clarify the direction of our future preparations,” said Jong-won Choi, Executive Director of the Development Division at Daewoong Pharmaceutical.

 

”The approval period was shorter than expected by two months with the help of the rolling review system.” Lunsumio Inj= Lunsumio Inj, a first-in-class CD20 and CD3 bispecific antibody treatment was designated as the No.1 GIFT drug, which allowed the review to begin immediately upon the submission of the application.

 

In particular, the fast-track designation and approval process fostered the conditions for faster access for patients, as domestic approval was prepared without any time lag from overseas regulatory review.

 

The number of patients with recurrent/refractory vesicular lymphoma in Korea increased from 885 in 2018 to 1,770 in 2022, and the number of patients is still increasing every year, increasing the disease burden on society.

 

“We were able to communicate with the reivewee frequently and quickly prepare the necessary materials for the review,” the MFDS said, adding that ”we were able to grant marketing authorization faster than the usual drug license review period.” Qarziba Inj=Qarziba, which is a treatment for high-risk and relapsed/refractory neuroblastoma was eligible to GIFT and other support benefits in the approval process as the No.1 ‘approval-evaluation-drug pricing negotiation project.’ The reviewers from the Expedited Review Division communicated frequently with the company representatives and actively delivered their inquiries and comments on the submitted data.

 

In particular, one of the benefits of GIFT is the opportunity to share opinions through supplementary briefings and frequent non-face-to-face consultations, which can be utilized through wired and wireless communication such as phone calls and emails, as well as opportunities such as product briefings and supplementary briefings.

 

In the case of safety and efficacy, criteria, and test methods, the first round of supplementation was already made, and the reviewers provided detailed and professional counseling in the video supplementation session requested by the company.