Biogen extends its setback streak as Japanese regulators push back against their controversial Alzheimer's drug
Another bad week for Biogen and its Tokyo-based partners at Eisai was extended on Wednesday with news that a panel review of their controversial Alzheimer’s drug aducanumab earned a pushback from the health ministry in Japan.
According to overnight news reports, their panel concluded that inconsistent Phase III data and lack of clinical significance in reducing amyloid plaque in patients made it difficult to determine if the therapy worked, but offered to review it again once the 2 partners lined up more data.
That latest pushback comes just days after Biogen and Eisai were forced to dig a defensive perimeter around the formal European regulatory decision against an approval and right on the heels of Biogen’s decision to slash the US price and begin a company reorganization as sales stagnate in the face of deeply embedded resistance to the drug — which offered one of the most controversial approvals in FDA history.
Biogen says it’s not giving up on Japan. In a statement sent to Endpoints News, a spokesperson noted:
The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai remain committed to bringing aducanumab to patients in Japan expeditiously.
Japan was seen as a possible opportunity to stop some of the bleeding over the disastrous rollout, with Eisai deeply entrenched in the country and looking to market what it and its partners insist is the first disease-modifying drug for Alzheimer’s. Eisai spearheaded the regulatory effort in Japan and stood to earn the lion’s share of the money from the big Asian market.
Experts, though, have shaken their heads in unison over a muddle of conflicting data, perplexed that the FDA would offer an accelerated approval based on the suspect theory that amyloid reduction would likely help patients fight back against the steady drain of their memories.
Those experts show no sign of going away, as we also saw this week with a lineup of researchers in the field who signed a petition demanding the FDA provide an accelerated withdrawal of the drug from the US market.
As of today, the FDA remains the sole premier drug agency in the world that thinks the drug should be on the market, based on what we know so far.