TGA delivers Biogen, Eisai a blow

Posted 17 October 2024 PM 

The TGA has delivered a blow to Biogen and Eisai in announcing to the public that it has refused registration of their Alzheimer's disease treatment Leqembi on the basis that the drug's "efficacy did not outweigh the safety risks".

While Eisai and Biogen are co-commercialising and co-promoting Leqembi, also known as lecanemab, Eisai serves as the head of Leqembi development and regulatory submissions globally. The Japanese firm also has the final decision-making authority.

To see the whole article, please login