Imlunestrant becomes first reviewed after new drug approval

Eli Lilly’s imlunestrant becomes the first drug to apply for marketing authorization after new drug approval fee hike

Eli Lilly submits application on January 31 after one preliminary consultation with the MFDS

A dedicated team for the drug review will be formed soon... approval is expected within 295 days

The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million.

 

According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and Drug Safety on Jan.

 

31.

 

This is the first new drug application filed since the MFDS drastically improved its new drug approval review process and revised the new drug approval review fee.

 

The MFDS implemented the New Drug Approval Innovation Plan on January 1, 2025, and introduced various improvements to increase the transparency and predictability of the approval process.

 

The biggest change is the introduction of a preliminary consultation process.

 

Previously, discussions could only be held after the submission of a new drug application, but now preliminary consultations can be held before submission to prepare for the approval process.

 

This allows companies to get an early indication on the direction of data required for their new drug approval applications and minimize unnecessary supplement requests.

 

Lilly has also already held one preliminary consultation session for Inrulio and the MFDS is currently finalizing the establishment of a dedicated team for its review within its organization.

 

In addition, during the first and second rounds of supplement requests, a process has been added to allow pharmaceutical companies to pre-register supplement materials and request a clarification meeting.

 

This will allow the MFDS to provide clear guidelines, and a final meeting will be held at the final review stage, which is expected to increase the consistency and efficiency of the approval process.

 

Based on such innovative measures, the MFDS aims to shorten the review period for new drugs to 295 days or less, and in particular, the GMP survey period has been significantly shortened from 12 months to 90 days.

 

This is expected to speed up the time for new drug releases.

 

Lilly's Inrulio is the domestically licensed name for imlunestrant, an oral selective estrogen receptor degrader (SERD).

 

The drug is being developed for the treatment of patients with estrogen receptor-positive (ER+), and hormone receptor 2-negative (HER2-) advanced breast cancer.

 

Results from the recently announced Phase III EMBER-3 trial showed that imlunestrant provided a statistically significant improvement in progression-free survival (PFS) compared to standard-of-care endocrine therapy (SOC ET).

 

In particular, patients with estrogen receptor 1 (ESR1) mutations experienced a 38% reduction in tumor worsening compared to conventional therapy.

 

In addition, the combination of imlunestrant and the CDK4/6 inhibitor Verzenio (abemaciclib) reduced the rate of tumor worsening by 43% compared to monotherapy, with a median progression-free survival of 9.4 months compared to 5.5 months for imlunestrant alone.

 

The findings were published in the New England Journal of Medicine (NEJM) and presented at the San Antonio Breast Cancer Symposium (SABCS).

 

This application is the first to be submitted since the implementation of the new drug approval innovation plan and will be an important test of how quickly and efficiently the MFDS’s new approval process will work.

 

The MFDS had said, “ We will establish a review system that stands at the global level through the new drug approval innovation plan.

 

The review process with increased transparency and predictability will contribute to strengthening the competitiveness of Korea’s pharmaceutical industry.” “This is a positive sign that the domestic new drug review process is evolving to a global level,” said a pharma and bio-industry official.

 

”If the new drug launch period is shortened through this innovation plan, domestic patients will be able to access innovative treatment options more quickly.” Another industry expert said, “If the MFDS's expedited approval process works smoothly, not only global pharmaceutical companies but also domestic biotech companies will be able to more actively engage in new drug development,” and “Increasing the efficiency of the new drug approval process will have a positive impact on the entire industry.”