FDA Expert Panel Endorses Takeda’s Antiviral Maribavir

The FDA’s Antimicrobial Drugs Advisory Committee gave Takeda Pharmaceutical’s investigational antiviral, maribavir, a unanimous thumbs-up in two 17-0 votes as a potential treatment for refractory human cytomegalovirus (HCMV) infections in post-transplant patients with or without genotypic resistance.

However, several members of the panel strongly recommended postmarket studies, not only to investigate the drug’s potential in neonatal and pediatric populations, but to keep an eye on its resistance potential, especially when used in combination with other antiviral medications.

There was little doubt, though, that the committee saw maribavir as an important tool in a serious, but difficult-to-manage consequence of the long-term immunosuppression necessary with both liquid and solid organ transplants.

“In the CMV field, it’s been many years since we’ve had a new product — especially an oral product — come to FDA for review,” said W. David Hardy, of the Charles Drew University School of Medicine and Science, Los Angeles, in the Oct. 7 meeting. “I believe this is an advance — even if an incremental advance — for a high-need patient population. We need further clarification about where it works best and potential resistance patterns, though.”