Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says

 
• By Sue Sutter

Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.

Slam dunk
Despite reservations about the pivotal trial, an FDA panel's vote for Takeda's maribavir was a slam dunk. • Source: Alamy

Takeda Pharmaceutical Co. Ltd.’s maribavir appears on track for a broad treatment indication in post-transplant patients with refractory/resistant cytomegalovirus infection following an unanimous US Food and Drug Administration panel endorsement of the candidate and rejection of the agency’s proposal to distinguish the targeted population based upon evidence of genetic resistance.

In separate 17-0 votes, the Antimicrobial Drugs Advisory Committee on 7 October said the overall benefit-risk assessment was favorable for maribavir’s use for post-transplant patients with CMV infection and disease refractory to treatment, with and

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