Biogen’s Alzheimer’s disease TX entry unclear in Korea

unable to pass Central Pharmaceutical Affairs Council

Expert council disapproves clinical trial results

Introduction of the world’s first Alzheimer’s disease treatment, ‘Aduhelm (aducanumab),’ has virtually become unclear in Korea.

 

The results of the Central Pharmaceutical Affairs Council meeting that was held on July 12th that was recently disclosed by the Ministry of Food and Drug Safety showed that the expert advisory board concluded that the application data filed for an Alzheimer’s disease treatment "was not sufficient to be accepted as a confirmatory clinical trial." Although the deliberated product's name and ingredient were not disclosed in the minutes of the meeting, one committee member mentioned, “Since the FDA approval, the US news had covered how the ‘Biogen's statisticians used magic' to become up with much analysis favorable to Biogen, which it had submitted for accelerated approval.” From the comment, it can be inferred that the item that was deliberated was Aduhelm, for which Biogen submitted an application for approval in July last year.

 

Aduhelm received conditional approval from the U.S.

 

FDA in June last year with a post-approval trial required to verify that the drug provides the expected clinical benefit.

 

The conditional approval made in the US was in itself not easy.

 

In November 2020, the company was unable to satisfy the primary endpoints in the EMERGE and ENGAGE trials, due to which the FDA advisory committee had decided to recommend non-approval due to insufficient evidence proving its effectiveness.

 

However, Biogen further analyzed its clinical data and received conditional approval from the FDA based on efficacy validated in the high-dose group.

 

The clinical trial results that Biogen submitted for marketing authorization in Korea were data that did not satisfy the primary and secondary efficacy endpoints.

 

One committee member said, “It is not reasonable to discuss approval when the data submitted did not achieve the primary efficacy endpoint.

 

The members of the FDA advisory committee opposed to the approval, but clinicians’ position was that the drug should be approved as there is no other treatment available and the biomarkers showed an effect.

 

Many of the advisory board members resigned, opposing the approval.” Another member said, “It is understandable that such discussions arise because there are currently no treatments available in the field of dementia treatment, but from a statistical point of view, there is no controversy that the data submitted was from a failed clinical trial.

 

We will not be accepting additional analysis results on the submitted data after declaring the data non-acceptable.” Most of the members agreed that the clinical data alone cannot be accepted as confirmatory clinical results, and the committee chair also said, “The biomarker part will be discussed afterward.

 

The conclusion that was made this time is that the Phase III clinical trial results cannot be accepted as a confirmatory trial.” Meanwhile, iBiogen’s CEO Michel Vounatsos had resigned at Biogen’s 2022 Q1 earnings release in May, taking responsibility for Aduhelm's poor performance, upon which Biogen announced that it would substantially eliminate its commercial infrastructure for Aduhelm.