2023Q1 FDA Drug Approvals

13 drugs were approved by the FDA in the first quarter of 2023; 4 of them for rare diseases, 3 for cancers.

Name — Active Ingredient — Disease Indication

1. Leqembi — lecanemab-irmb — To treat Alzheimer’s disease
2. Brenzavvy — bexagliflozin — To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
3. Jaypirca — pirtobrutinib — To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor (cancer)
4. Orserdu — elacestrant — To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer (cancer)
5. Jesduvroq — daprodustat — To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
6. Lamzede — velmanase alfa-tycv — To treat non-central nervous system manifestations of alpha-mannosidosis (rare)
7. Filspari — sparsentan — To reduce proteinuria in adults with primary immunoglobulin A nephropathy (Berger’s disease) at risk of rapid disease progression
8. Skyclarys — omaveloxolone — To treat Friedrich’s ataxia (rare)
9. Zavzpret — zavegepant — To treat migraine
10. Daybue — trofinetide — To treat Rett syndrome (rare)
11. Zynyz — retifanlimab-dlwr — To treat metastatic or recurrent locally advanced Merkel cell carcinoma (cancer)
12. Rezzayo — rezafungin — To treat candidemia and invasive candidiasis
13. Joenja — leniolisib — To treat activated phosphoinositide 3-kinase delta syndrome [APDS] (rare)

brain-1 icon by Servier https://smart.servier.com/ is licensed under CC-BY 3.0 Unported https://creativecommons.org/licenses/by/3.0/