BRIEF—FDA accepts Takeda's maribavir NDA for priority review

The US Food and Drug Administration has accepted for priority review a New Drug Application (NDA) for maribavir, submitted by Japanese pharma major Takeda Pharmaceuticals, for the treatment of cytomegalovirus (CMV) infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

This is an inflection year for Takeda’s pipeline with up to six regulatory submissions and four potential approvals anticipated by the end of fiscal year 2021.

If approved, maribavir has the potential to change the treatment landscape for post-transplant CMV, and the acceptance of this regulatory application is an important milestone on maribavir’s path forward, Takeda noted.

The maribavir NDA acceptance is Takeda’s fourth new molecular entity accepted for regulatory review in six months, following the FDA submissions of TAK-721 for the treatment of eosinophilic esophagitis, mobocertinib for the treatment of EGFR Exon20 insertion mutation positive metastatic non-small cell lung cancer, and the European Medicines Agency submission of the company’s dengue vaccine candidate (TAK-003), which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60.