Lantidra

donislecel

Approval

ApplicationBLA 125734

Approval dateJun 28, 2023

Approval year2023

SponsorCellTrans Inc

FDA-approved use

the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA-approved label (PDF)

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Lantidra:

"What was the basis for Lantidra's approval — what trials, what endpoints?"
"What adverse events did the FDA flag in the Lantidra medical review?"
"What regulatory pathway did Lantidra use — priority review, breakthrough, accelerated approval?"