Insights+: The US FDA New Drug Approvals in July 2024

Shots:    

• PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024    
• The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry      
• The major highlighted drug was Eli Lilly’s Kisunla for the treatment of early symptomatic Alzheimer’s disease 

1. Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease 

Active Ingredient: Donanemab-azbt 

Approved: July 02, 2024 

Company: Eli Lilly 

Disease: Alzheimer’s Disease 

Shots:  

• The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer’s disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development 
• The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) & confirmed Alzheimer’s pathology in 2 groups, one with less advanced disease & other having overall population 
• Results depicted a 35% slow decline in less advanced Alzheimer’s patients & 22% in the overall population on the iADRS, with a 39% reduced risk of progression to the next clinical stage. Amyloid plaques were reduced by 61% (6mos.), 80% (12mos.) & 84% (18mos.) in the overall population 

2. Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata 

Active Ingredient:  Deuruxolitinib 

Approved: July 25, 2024  

Company: Sun Pharma  

Disease: Severe Alopecia Areata 

Shots:   

• The US FDA has granted approval to the company’s Leqselvi (8mg) tablets for treating severe alopecia areata adults 
• Approval was supported by two P-III (THRIVE-AA1 & THRIVE-AA2) studies that assessed the scalp hair regrowth using the SALT score with Leqselvi (8mg or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata post 24wks. across the US, Canada & EU 
• Avg. patients had 13% of scalp hair coverage at baseline. Study reached the 1EP, showing ≥80% scalp hair coverage (SALT ≤20) among 30% of patients with a consistent upward trend & no plateau after 24wks.; ~25% regained their scalp hair (≥90% coverage) 

Related Post: Insights+: The US FDA New Drug Approvals in June 2024