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  • ¡®Policy support enabled the prompt approval of Envlo¡¯
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Sep 4, 2024 05:49am
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
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