FDA rejection to delay Lebrikizumab chances to enter atopic dermatitis market: GlobalData

The FDA recently rejected Eli Lilly’s biologic license application (BLA) for their anti-interleukin (IL) -13, lebrikizumab, which is in development for the treatment of atopic dermatitis (AD). This news will likely delay lebrikizumab’s entry into the US market and therefore affects the agent’s chances to compete directly with agents such as Sanofi and Regeneron’s first-to-market anti-IL-4/13 Dupixent (dupilumab) and LEO Pharma’s anti-IL-13 Adbry/Adtralza (tralokinumab), says GlobalData.

Ramla Salad, Pharma Analyst at GlobalData, comments, “Following the addressing of concerns highlighted in the complete response letter (CRL), Lilly’s re-submission of lebrikizumab’s BLA to the FDA would fall under a Class 1 re-submission, and therefore, the complete regulatory review should take two months from the receipt date. GlobalData currently expects Lilly to resubmit lebrikizumab’s BLA in Q4 2023.”

Despite this setback, the CRL being issued was not because of inadequacies or concerns regarding lebrikizumab’s Phase III efficacy and safety data that supported the BLA to the FDA or concerns with the proposed US label of the product. This means that the agent is still considered to be a viable therapeutic option for patients suffering from moderate to severe AD.

According to GlobalData’s report on AD, the market for this indication is anticipated to reach $17.4 billion in 2030 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan). Of the $17.4 billion, the interleukin-inhibitor drug class is anticipated to contribute $8.5 billion.

Salad concludes, “Within the interleukin inhibitor drug class and in the overall moderate-to-severe market, Dupixent is forecast to reach sales of $6.1 billion across the 7MM for AD in 2030. Upcoming players such as Eli Lilly are hoping to compete more directly with the IL-4/13 inhibitor, which has captured a substantial market share across all patient groups and geographies.