Lilly Receives Complete Response Letter from FDA for Lebrikizimab

Eli Lilly and Company (Lilly) announced on Oct. 2, 2023 that it received a complete response letter (CRL) from FDA for the biologics license application (BLA) for lebrikizumab, a candidate for treating moderate-to-severe atopic dermatitis (eczema).

The letter cited findings that arose during the multi-sponsor inspection of a third-party, contract manufacturing organization that included a monoclonal antibody drug substance used in lebrikizumab. However, the CRL stated no concerns about the clinical data package, safety, or label for lebrikizumab. No other marketed or pipeline Lilly products are affected, according to a company press release.

Lilly has submitted data from three studies (ADvocate 1, ADvocate 2, and Adhere), which included more than 1000 adults and adolescents, from ages 12 to older, who have moderate-to-severe eczema and who were unable to control symptoms with topical medicines or other systemic treatments.

"We are confident in lebrikizumab's potential to help people living with eczema and in the clinical data that supports our submission package for the medicine," said Patrik Jonsson, Lilly executive vice-president, president of Lilly Immunology and Lilly USA, and chief customer officer, in the press release. "We will continue to work closely with the third-party manufacturer and [FDA] to address the feedback in order to make lebrikizumab available to patients."

News of the CRL occurred within the same week that Lilly announced a major $1.4-billion acquisition of radiopharmaceutical company, POINT Biopharma Global. This acquisition will boost Lilly’s oncology pipeline with both clinical and preclinical-stage radioligand therapies under development for treating cancers.

Source: Eli Lilly and Company