Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Indication/mechanism-related claims are partially supported by the provided label excerpts (plaque psoriasis indication is supported; IL-23 receptor target and monoclonal antibody are supported). However, the ankylosing spondylitis indication is not supported by the provided labeling excerpts (no such indication shown). Patent ownership/expiration and generic/biosimilar availability are not addressed in the provided FDA label excerpts, rendering those statements unsupported.
Category Scores
Accurate Statements
Skyrizi is a medication used to treat moderate to severe plaque psoriasis.
Supported by 1.1 Plaque Psoriasis: indicated for moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years and older.
Skyrizi is risankizumab-rzaa.
Supported by Drug/Active ingredient(s): SKYRIZI (risankizumab-rzaa) and 11 Description: Risankizumab-rzaa...
Risankizumab-rzaa is a humanized monoclonal antibody.
Supported by 11 Description and 12.1 Mechanism of Action description of a monoclonal antibody (IL-23 antagonist monoclonal antibody).
Risankizumab-rzaa targets the interleukin-23 (IL-23) receptor.
Supported by 12.1 Mechanism of Action: binds p19 subunit of IL-23 and inhibits IL-23 receptor interaction.
Unsupported Statements
Skyrizi is a medication used to treat active ankylosing spondylitis.
Not supported by the provided FDA label excerpts (no ankylosing spondylitis indication is shown in the provided sections).
The Skyrizi patent (US10745493) is owned by AbbVie Pharmaceuticals.
Patent ownership information is not present in the provided prescribing information excerpts.
The Skyrizi patent (US10745493) is set to expire on August 3, 2029.
Patent expiration information is not present in the provided prescribing information excerpts.
There are no generic versions of Skyrizi approved for the US market.
Generic/biosimilar market-availability statements are not included in the provided prescribing information excerpts.
There are no biosimilar versions of Skyrizi approved for the US market.
Generic/biosimilar market-availability statements are not included in the provided prescribing information excerpts.
Contradictions
Important Omissions
No label excerpt was evaluated for other Skyrizi indications listed in the provided prescribing information (psoriatic arthritis, Crohn’s disease, ulcerative colitis) in the set of claims provided.
Importance:
Low
Safety Assessment
Potential Patient Risk:
Moderate
The ankylosing spondylitis indication claim is not supported by the provided labeling excerpts; if acted upon, it could lead to off-label/inaccurate use. Other unsupported claims concern patents/availability rather than direct clinical use.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
One clinical indication claim (active ankylosing spondylitis) is not supported by the provided FDA label excerpts, and multiple non-label statements (patent ownership/expiration and generic/biosimilar availability) are unsupported.
Suggested Improvement
Remove or revise the ankylosing spondylitis indication claim to match the provided labeling (plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis). Omit patent ownership/expiration and generic/biosimilar availability statements unless supported by the provided labeling excerpts.