Janssen’s Spravato required to submit domestic trial data

after failing to demonstrate efficacy in clinical trials in Chinese and Japanese patients

Central Pharmaceutical Affairs Council orders company to Submit Phase III clinical trial-level data in Koreans

Was unable to demonstrate efficacy overseas…the information needs to be shared among experts in Korea

With Janssen’s novel drug for treatment-resistant depression (TRD), ‘Spravato Nasal Spray (esketamine hydrochloride)’ failed to demonstrate efficacy in Japanese and Chinese patients, the Korean authorities also held discussions on whether to maintain its marketing authorization status in Korea as well.

 

The drug was approved in June 2020.

 

As a result, the authorities decided that no immediate action such as suspension of sales should be taken as no results have shown that the drug was ineffective in Korea.

 

However, the company will be required to submit Phase III clinical trial-level data to further prove its efficacy.

 

For now, the product has been kept on the shelves, but attention will continue to be focused on whether or not it will remain on the shelves by demonstrating its efficacy in Koreans.

 

According to the industry on the 8th, according to the minutes of the Central Pharmaceutical Affairs Council that was released by the Ministry of Food and Drug Safety, the CPAC held an advisory meeting on whether to maintain the marketing authorization (sales) of the medical narcotic drug Stravato and whether it would need to further demonstrate its efficacy.

 

Janssen representatives that had been present at the CPAC meeting, explained “The trials in Chinese and Japanese patients failed due to the lack of statistical significance in the efficacy endpoint.

 

The failure was due to an unexpectedly high placebo effect, which resulted in a lack of significant difference between the Stravato and placebo group, and it is difficult to judge this as a lack of efficacy because the MADRS (Montgomery-Asberg Depression Rating Scale) score did fall with the use of Stravato.

 

In particular, the initial clinical design, which was designed based on FDA guidelines, did not include Korean patients, as Korea does not require data from its own population for approval, so no efficacy data for Koreans are available.

 

Regarding the CPAC member’s question on whether the company can demonstrate Stravato’s efficacy in Koreans at the level of the Phase III clinical trial conducted at the time of initial approval, Janssen said, "The number of subjects had been about 200 to 300, so it may be difficult to recruit the same with Koreans alone, but we are currently working hard on post-marketing surveillance, and we have collected about 70 safety stories and efficacy assessment statements from patients.

 

We will add more number of subjects by the end of the 6-year period." Janssen added that the results of a one-year, single-arm, open-label clinical trial involving 26 Koreans and an investigator-initiated multicenter trial are underway.

 

After Janssen’s explanation, the CPAC chair said, "The CPAC acknowledges that the drug cannot be said to be effective in Japan and China, that is, Asia.

 

We need to decide whether to go through the process of receiving and reviewing the use status, clinical efficacy, and additional supplementation plans through the company or make a decision here and now." After discussions, the CPAC has decided to wait for further clinical data to be submitted rather than make an immediate decision, such as the suspension of sales.

 

In the process, the CPAC concluded that the changes to the labeling information (the drug has not been proven effective in Chinese and Japanese people) should be shared with experts and that it is necessary to receive opinions from doctors organizations, and mental health associations that actually prescribe the drug on-site.