March 2023 New Drug Approvals
Joenja: JOENJA is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.(1)
Rezzayo: REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO. (2)
Zynyz: ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. (3)
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (3)
Daybue: DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. (4)
Zavzpret: ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. (5)
Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.(5)
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