Aphexda

motixafortide

Approval

ApplicationNDA 217159

Approval dateSep 8, 2023

Approval year2023

SponsorAyrmid Pharma

FDA-approved use

To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA Drug Trials Snapshot

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 Aphexda:

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