"What are the Potential Safety Risks of Imcivree (Setmelanotide) with Hypersensitivity, According to FAERS?"

The FAERS Potential Signals of Serious Risks/New Safety Information listed Imcivree (setmelanotide) with Hypersensitivity as a potential signal on their October - December 2023 listing.

Analyzing the FAERS data up to 2024 Q1 for reports submitted with this drug as the primary suspect drug, the PRR for Hypersensitivity is greater than 2 when comparing the drugs within their ATC groups: ALIMENTARY TRACT AND METABOLISM, ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS, and CENTRALLY ACTING ANTIOBESITY PRODUCTS.

SETMELANOTIDE ATCs	PRR	MGPS	BCPNN	ROR	CHISQ
ALIMENTARY TRACT AND METABOLISM	7.62977	7.2714	43.54003	7.63125	21.79841
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS	9.68774	9.21814	35.11641	9.72839	29.49423
CENTRALLY ACTING ANTIOBESITY PRODUCTS	7.48836	7.13763	31.04399	7.59927	21.32225

Hypersensitivity is included in two SMQs (Angioedema (SMQ) and Drug reaction with eosinophilia and systemic symptoms syndrome (SMQ)) under the broad scope category and Hypersensitivity (SMQ) under the narrow scope category. No other adverse events have been reported for SETMELANOTIDE under the HLT Allergic conditions NEC. Hypersensitivity is not included in the EMA IME list. The FDA has added additional information related to this.