Lilly Resolves US FDA Concerns About Emgality TV Ads That Were Not Meant To Run Solo

With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.

Paralympics_Allysa Seely
Paratriathlete and gold medalist Allysa Seely appeared in a TV ad for Lilly's migraine drug Emgality • Source: Alamy

The US Food and Drug Administration’s objections to two television ads for Eli Lilly and Company’s migraine drug Emgality (galcanezumab-gnlm) were so quickly quelled that the agency posted its untitled letter and a close-out letter at the same time. It is the first time the Office of Prescription Drug Promotion has posted these letters simultaneously.

On 13 December, OPDP sent an untitled letter to Lilly stating that two of its direct-to-consumer broadcast TV ads failed to include any risk information and omitted major side effects and contraindications associated with Emgality

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