RX Insights from December '25

This month's edition provides a focused review of newly approved and recently launched therapies. Expion Health monitors these developments closely to assess clinical relevance, therapeutic positioning, and potential implications for payers, providers, and patients.

ARMLUPEG

Indication: A biosimilar to Neulasta (pegfilgrastim) reducing infection risk from febrile neutropenia in chemotherapy patients. The seventh FDA-approved Neulasta biosimilar.

WASKYRA

Indication: Cell-based gene therapy for Wiskott–Aldrich syndrome (WAS).

Clinical Data: 93% reduction in severe infections within 6–18 months post-treatment; 60% reduction in moderate/severe bleeding in first 12 months.

NUZOLVENCE

Indication: Treatment of uncomplicated urogenital gonorrhea, addressing antibiotic resistance. Single 3-gram oral dose.

Clinical Data: 91% clinical cure vs 96% for standard ceftriaxone plus azithromycin therapy (n=930).

BLUJEPA

Indication: Treatment of uncomplicated urogenital gonorrhea in patients 12+.

Clinical Data: Phase 3 EAGLE-1 trial (n=628): 93% clinical cure vs 91% for standard therapy.

RYBREVANT FASPRO

Indication: First subcutaneous therapy for EGFR-mutated NSCLC.

Clinical Data: Phase 3 PALOMA-3: 65% alive at 12 months vs 51% for IV RYBREVANT.

EXDENSUR

Indication: Add-on maintenance treatment for severe eosinophilic asthma, ages 12+. IL-5 antagonist dosed twice yearly.

Clinical Data: SWIFT 1 and SWIFT 2 trials: 58% and 48% reduction in annualized asthma attacks respectively.

AQVESME

Indication: First approved therapy for alpha-thalassemia; first oral treatment for beta-thalassemia in adults.

Clinical Data: ENERGIZE-T trial: transfusion reduction response in 30% vs 13% placebo.

YARTEMLEA

Indication: First FDA-approved treatment for transplant-associated thrombotic microangiopathy (TA-TMA).

Clinical Data: Single-arm study (n=28): 61% TMA response rate.

MYQORZO

Indication: Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Carries boxed warning for heart failure due to systolic dysfunction.

Clinical Data: Phase 3 SEQUOIA-HCM trial (n=282): statistically significant improvement in peak oxygen uptake vs placebo.