After FDA no, Almirall’s eczema drug gets EU okay

The European Commission has approved Almirall’s lebrikizumab as Ebglyss for the treatment of moderate-to-severe atopic dermatitis (AD), with an EU rollout set to start in Germany next year.

The green light comes just a few weeks after quality compliance problems at a contract manufacturing organisation prompted the FDA to reject a marketing application for the IL-13 inhibitor filed by Eli Lilly, which holds US rights to the drug stemming from its $1.1 billion acquisition of Dermira in 2020.

Ebglyss has been cleared in the EU for use in patients with AD aged 12 and over and with a minimum weight of 40kg who have symptoms severe enough to warrant systemic therapy and will enter the market in opposition to some heavyweight competition, notably Sanofi and Regeneron’s IL-4 and Il-13 inhibitor Dupixent (dupilumab).

Privately-held Almirall has said that lebrikizumab is its most important product launch for several years, and the approval comes after a somewhat turbulent period for the company, punctuated by a change in chief executive and the start of a drive to expand its pipeline, as well as possible plans for a public listing.

Evaluate Pharma has previously said that worldwide annual sales for lebrikizumab could peak at around $1.5 billion in 2028, which is a long way off the projected $7 billion peak sales for Dupixent in AD alone, but potentially transformative for Almirall, which reported total revenues of €878 million in 2022.

“The EC approval of lebrikizumab for people suffering with moderate-to-severe AD provides another much-needed treatment option for this challenging disease,” said Almirall’s chief medical officer, Dr Volker Koscielny.

“We are confident that, due to its demonstrated short and long-term efficacy, with monthly maintenance dosing and a consistent safety profile, it has the potential to become a first-line biologic treatment,” he added.

That once-monthly dosing in the maintenance phase is a key point of difference for Almirall and Lilly, as the Dupixent drug needs to be administered every other week. They also point to lebrikizumab’s safety profile, including low rates of conjunctivitis, which is a known side effect of Dupixent.

In trials, Ebglyss showed good and durable efficacy, with 80% of patients who responded to treatment at week 16 maintaining skin clearance and itch relief through one year of maintenance treatment.

Dupixent is also approved to treat other inflammatory diseases, including severe asthma, chronic rhinosinusitis with nasal polyps, and others, helping it to more than $8.8 billion in sales last year.

Almirall and Lilly also want to extend the indications for lebrikizumab, with trials ongoing in idiopathic pulmonary fibrosis (IPF), although, Adis reports that studies in some other uses, including asthma and chronic obstructive pulmonary disease (COPD), have been discontinued.

The IL-13 inhibitor is also under regulatory review in the UK, with a decision possible before the end of this year, while Almirall is also working towards approval in Switzerland before the end of 2024.