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On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

This is not the first CRL received by the US-based company; on 13 April, the FDA rejected Lilly’s application for ulcerative colitis detailing similar issues pertaining to the proposed manufacturing of mirikizumab, citing findings that arose during a multisponsor inspection.

The regulator raised no concerns about the clinical data package or label for the medicine.

The recent setback may affect lebrikizumab’s timeline to enter the US AD market and 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).

Following the addressing of concerns highlighted in the CRL, Lilly’s resubmission of lebrikizumab’s BLA to the FDA would fall under a Class 1 resubmission, and therefore, the complete regulatory review should take two months from the receipt date; GlobalData currently expects Lilly to resubmit lebrikizumab’s BLA in the fourth quarter of 2023. 

Therefore, Lilly will likely liaise closely with the FDA and the third-party manufacturer to address the feedback, so as not to further delay the approval.

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By GlobalData

Despite this setback, the CRL being issued was not a result 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 $17.4bn in 2030 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan).

Of this $17.4bn, the interleukin-inhibitor drug class is anticipated to contribute $8.5bn in 2030 across the 7MM.

Within the interleukin inhibitor drug class and in the overall moderate-to-severe market, it is clear that the market leader is Dupixent, which is forecast to reach 2030 sales of $6.1bn across the 7MM for AD.

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.

Despite the intense competition expected within the interleukin class, it is important to note that not all patients respond to Dupixent, so there is always the possibility of lebrikizumab capturing market share, especially with the presence of treatment-refractory patients.

Despite the latest setback, lebrikizumab is still expected to be the third targeted biologic and the second selective anti-IL-13 to be approved for the treatment of moderate-to-severe AD in adults and adolescents in the US, behind well-established marketed assets such as Dupixent and Adbry.