Problems at a contract manufacturing organisation have scuppered Eli Lilly’s hopes of a timely FDA approval for lebrikizumab, its IL-13 inhibitor for the treatment of atopic dermatitis or eczema.
The complete response letter (CRL) from the US regulator did not mention any concerns about the clinical data package, safety or label for lebrikizumab, raising the hope that any delay will not be too long – assuming the issues at the CMO can be resolved or production switched to a new partner.
The CMO is involved in the production of the monoclonal antibody drug substance, according to Lilly, which said no other drugs are affected by the CRL. The company said it will “continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients.”
The delay is something of a boost to Sanofi and Regeneron, whose blockbuster IL-4 and Il-13 inhibitor Dupixent (dupilumab) currently leads the atopic dermatitis market, given that lebrikizumab has previously been predicted to become a $1.5 billion by 2028, according to Evaluate estimates.
That’s still well short of the $7 billion in peak atopic dermatitis sales predicted for Dupixent, but lebrikizumab remains an important new product for Lilly and one of four new drugs it has said should launch this year. The drugmaker acquired it as part of its $1.1 billion takeover of Dermira in 2020.
In Europe – where rights to lebrikizumab are held by Almirall – things are progressing more smoothly with the drug as it was recommended for approval by the EMA’s human medicines committee, the CHMP, last month.
The CRL comes amid a poor run of form for Lilly in bringing drugs to market on schedule, given that the FDA also turned down approval of its anti-IL-23p19 antibody mirikizumab for ulcerative colitis and Crohn’s disease in April, once again because of manufacturing issues.
In January, the US regulator also refused to allow a filing for accelerated approval of Alzheimer’s disease therapy donanemab, forcing the drugmaker to wait for the outcome of a phase 3 trial and file for full approval, a process it completed in July.
Lebrikizumab, mirikizumab, donanemab and recently-approved Jaypirca (pirtobrutinib) for mantle cell lymphoma were all marked down for a launch in 2022, and along with Mounjaro (tirzepatide) for diabetes and potentially obesity are a new generation of growth products that Eli Lilly is anticipating will help drive its revenue growth in the coming years.
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