New advances from the pharmaceutical company Almirall in its flagship drug against atopic dermatitis. the latest clinical trials of Lebrikizumab. Until then, the results, which were presented at the American Congress of Dermatology, showed that more than 50% of patients with moderate to severe atopic dermatitis experienced a reduction of at least 75% in the severity of the disease at the 16 weeks after being treated. This Tuesday, two and a half months after the company reported these data, it announced the results of the one-year analyzes. These results show that 80% of patients achieved a clinical response with lebrikizumab monotherapy at 16 weeks and maintained skin lightening after one year of treatment with a regimen of every two weeks or every four weeks.
With these promising results, the pharmaceutical company plans to submit a marketing authorization application for the drug to the European Medicines Agency (EMA), as indicated in the first instance, at the end of the year. The drug’s business volume in Europe is around 450 million at peak sales. The American company Lilly, which owns the right to the drug in the US and in the rest of the world except Europe, also plans to submit an application to the US Food and Drug Administration (FDA) this year.
The dermatological drug was a commercial bet that Almirall made in June 2019. It was then that it disbursed 50 million dollars, which added to the 30 to reserve the license option, amounted to 80 million. However, this figure is only half of the total amount that Almirall will have to pay. If the medicine obtains the yes of the European Medicines Agency and consumes its first commercial sale, the company of the Gallardo family must pay another 85 million dollars to the American company.
Atopic dermatitis is a chronic, relapsing and heterogeneous skin disease characterized by intense itching, dry skin and inflammation. Although it is most often considered a childhood disease, it can appear at any age and affects 2-10% of adults worldwide.
These studies are part of the extensive lebrikizumab clinical development program evaluating more than 2,000 patients. The company will release the full one-year results of the late-stage monotherapy studies at upcoming conferences and in publications in 2022, and the company is already enrolling further late-stage clinical trials for the drug in atopic dermatitis.
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