Takeda Pharmaceutical Co. Ltd. is looking forward to US FDA action on two novel agents during the month of November. If they are both approvals, they could provide welcome new storylines after the company pulled the BLA for its dengue vaccine Qdenga in July and decided to withdraw targeted lung cancer therapy Exkivity (mobocertinib) from the market last month following failed in a Phase III confirmatory trial.
Takeda’s TAK-755 – an enzyme replacement therapy combining apadamtase alfa and cinaxadamtase alfa – is first up with a 16 November 2023 user fee goal date for congenital thrombotic thrombocytopenic purpura (cTTP)