Our client’s investigation drug candidate was being reviewed by the FDA for approval
As a new compound entity, the FDA required a public Advisory Committee to debate the drug candidate’s benefits versus risks
Challenge
The investigational drug demonstrated similar, but not superior, efficacy to incumbent product that was already on the market for 20 years
Safety evaluation trended towards inferiority to the market standard in critical patient populations although overall safety was noninferior
The public has a live in person opportunity to express opinions for the Committee to consider
Resolution
Xelay Acumen developed and implemented a strategic grass roots campaign to develop patient, provider, and professional society advocacy which would be able to participate in the oral public hearing during the Advisory Committee
Client enjoyed a monopoly of all speaker slots in support of the drug candidate, the turning point in a 15-1 vote in favor for the client and eventual drug approval by the FDA