The US FDA New Drug Approvals in April 2025  

Shots:     

• PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025      

• The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry       

• The major highlighted drug was Johnson & Johnson’s Imaavy securing approval for treating Generalized Myasthenia Gravis   

1. Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN) 

               Company: Novartis 

               Product: Vanrafia 

               Active Ingredient: Atrasentan 

               Disease: Primary IgA Nephropathy 

               Date: Apr 02, 2025   

Shots: 

• The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 

• Trial assessed atrasentan (0.75mg, PO, QD) + RAS inhibitor, unless intolerable, vs PBO in mentioned pts (n=340) for ~132wks. 64 pts on SGLT2 inhibitor dose for over 12wks. were also recruited (exploratory arm) 

• Trial showed 36.1% proteinuria reduction as early as 6wks., sustained through Wk. 36 (1EP), with UPCR benefit consistent across subgroups of main cohort & in the exploratory arm (37.4% reduction in UPCR) 

2. Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC) 

               Company: Akeso 

               Product: Penpulimab-kcqx 

               Active Ingredient: Penpulimab-kcqx 

               Disease: Nasopharyngeal Carcinoma 

               Date: Apr 23, 2025   

Shots: 

• The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy 

• Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal AK105-202 study assessing penpulimab-kcqx across two stages of metastatic NPC; data to be presented at AACR 2025 

• Penpulimab-kcqx (PD-1 mAb) was initially developed by Akeso, with subsequent development & commercialization handled via a joint venture with Chia Tai-Tianqing Pharmaceutical Group 

3. Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG) 

               Company: Johnson & Johnson 

               Product: Imaavy 

               Active Ingredient: Nipocalimab-aahu 

               Disease: Generalized Myasthenia Gravis 

               Date: Apr 29, 2025   

Shots: 

• The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing 

• Trial showed superior disease control per MG-ADL score & a rapid, sustained reduction in autoantibody levels by up to 75% from the 1st dose over 24wks; responses were sustained till 20mos. of follow-up in the ongoing OLE study 

• The P-II/III (Vibrance-MG) pediatric trial met its 1EP, with Imaavy (IV, Q2W) + SoC showing a 69% total serum IgG reduction over 24wks. along with 2EPs of improved MG-ADL & QMG scores 

Related Post: Insights+: The US FDA New Drug Approvals in March 2025