Eli Lilly ( LLY Quick Quote LLY - Free Report) announced positive top-line data from one-year analyses of two phase III studies, namely ADvocate 1 and ADvocate 2, which evaluated its IL-23 monoclonal antibody (mAB) candidate lebrikizumab to treat patients with moderate-to-severe atopic dermatitis (AD or eczema).
Overall data from both studies showed that eight out of 10 patients who were administered lebrikizumab monotherapy and experienced at least 75% reduction in disease severity (EASI-75) at 16 weeks of initial treatment, maintained improvements in skin clearance and disease severity at one year of treatment. In fact, patients administered lebrikizumab also showed improvements in itch over a period of one year.
In the year so far, shares of Eli Lilly have risen 9.8% compared with the
industry’s 3.7% increase. Image Source: Zacks Investment Research
Based on this data, Eli Lilly plans to file a biologics license application (BLA) with the FDA in second-half 2022, which will seek approval for lebrikizumab to address AD indication. Following the FDA filing, LLY also plans to file regulatory applications with other regulators across the globe, seeking approval for the candidate to treat the given indication.
Eli Lilly out-licensed exclusive rights for developing and commercializing lebrikizumab in Europe to Spain-based Almirall, which also plans to submit these results to the European health regulator later this year.
We note that Eli Lilly is also evaluating other drugs in the AD space. LLY along with partner
Incyte ( INCY Quick Quote INCY - Free Report) developed their JAK inhibitor drug Olumiant for the AD indication.
Earlier this year, both Eli Lilly and Incyte received a complete response letter (CRL)to their supplemental new drug application (sNDA), which sought approval for Olumiant in adults with moderate-to-severe AD. The CRL was issued by the FDA as LLY was not in alignment with the regulatory agency on the indicated population.
Eli Lilly/Incyte’s Olumiant is already approved in more than 50 countries, including the European Union and Japan, to treat AD in adults who are candidates for systemic therapy.
Olumiant is currently approved in the United States for treating adults with moderate-to-severe rheumatoid arthritis (RA). Last month, Olumiant
received full approval from the FDA to treat COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Notably, the target market is highly competitive as Eli Lilly’s AD drugs face stiff competition from Dupixent, a blockbuster drug developed by
Regeneron ( REGN Quick Quote REGN - Free Report) in partnership with Sanofi ( SNY Quick Quote SNY - Free Report) .
Regeneron/Sanofi’s Dupixent is approved by the FDA to treat individuals aged six years and above with moderate-to-severe AD that is not well controlled with prescription therapies used on the skin (topical) or who cannot use topical therapies. Apart from AD, the drug is also approved in the United States to treat certain patients — of different age populations — with chronic rhinosinusitis with nasal polyposis, asthma and eosinophilic esophagitis.
Dupixent is jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.For first-quarter 2022, Dupixent generated global net sales worth $1.8 billion, reflecting a 43% year-over-year rise.
Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .