FDA Approval Report

Title: The US FDA New Drug Approvals in July 2024

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

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)