Eli Lilly: EMGALITY (galcanezumab-gnlm)
FDA untitled letter, 13 December 2021. Two direct-to-consumer TV ads featuring Team USA athletes suggested Emgality's use for migraine but gave no risk information, no brief summary or adequate provision, an incomplete indication, and were not submitted to FDA at first publication.
The letter
- Date
- 13 December 2021
- Type
- Untitled letter (OPDP)
- Product
- BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use (BLA 761063)
- FDA matter number
- MA 558
- Promoted piece
- TV ads 'The Journey Forward: Ryan Murphy' and 'Allysa Seely'
- Aimed at
- Consumers (DTC)
- Format
- TV ad, Spokesperson or influencer
- Came in under Form FDA 2253
- The letter does not say
- Close-out
- FDA closed the matter out on 12 January 2022, 30 days after the letter.
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Omits or minimizes risk
“By omitting the major side effects and contraindications associated with Emgality, the TV ads fail to provide material information about the consequences that may result from the use of the drug”
- Missing required disclosure
“The TV ads also fail to either provide adequate provision or a brief summary as required by 21 CFR 202.1(e)(1).”
- Not submitted on Form 2253
“A copy of each TV ad was not submitted to OPDP under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.