Chronic Spontaneous Urticaria Indication for Dupixent
On April 18, 2025, the US Food and Drug Administration (FDA) approved Sanofi and Regeneron’s Dupixent® (dupilumab) for chronic spontaneous urticaria (CSU) in people 12 years of age and older whose symptoms persist despite antihistamine treatment. According to Regeneron, an estimated 300,000 Americans will be eligible for treatment with Dupixent for CSU. In clinical trials, patients treated with Dupixent experienced a statistically significant reduction in itch severity and urticaria activity. Dupixent showed a 30% complete response rate compared to an 18% complete response in the placebo group. The recommended dose for treating CSU is an initial dose of 600mg with two 300mg subcutaneous (SC) injections, followed by 300mg given every other week. Dupixent, an interleukin-4 receptor alpha antagonist, also has indications for treating atopic dermatitis, eosinophilic esophagitis (EoE), certain types of asthma and chronic rhinosinusitis with nasal polyposis, chronic obstructive pulmonary disease (COPD) and prurigo nodularis. Revised prescribing information is here.
Jynarque Generic Approved
Lupin announced FDA approval of tolvaptan tablets on April 24, 2025. Tolvaptan 15mg, 30mg, 45mg, 60mg and 90mg tablets are bioequivalent to Otsuka’s Jynarque® (tolvaptan). Indicated to slow the decline of kidney function in autosomal dominant polycystic kidney disease, it is estimated that US annual sales were $1,467 million in 2024. This is the first generic to Jynarque. Lupin is the first to file for this product and, therefore, is eligible for 180 days of exclusivity. The launch plan is not yet known; however, Lupin states it will launch soon. Prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached.
Opioid Epidemic Update and Relevant Pipeline Review Issues Document The opioid epidemic has highlighted the need for pain management guidance as well as medications to treat opioid use disorder and overdose reversal agents. With the evolution of this epidemic, a first-in-class, non-opioid analgesic was approved in January 2025. This document is intended to provide an update on opioid reversal agents, medications for opioid use disorder (MOUD) and pain management, including relevant pipelines.