(Adnkronos) - Si tratta del primo trattamento in crema specificamente indicato per pazienti adulti affetti da questa patologia per i quali i corticosteroidi topici sono inadeguati o inappropriati. L'approvazione per tutti i paesi dell’Unione europea segue il recente parere positivo del Comitato per i medicinali per uso umano dell'Agenzia europea per i medicinali e si basa sui risultati del programma di studi clinici Delta 1, 2 e 3.
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00:00The European Commission has granted permission to import Delgocitinib into the market.
00:11The first cream for the treatment of adult patients with chronic eczema of the hands from moderate to severe, for which corticosteroids are inadequate or inappropriate.
00:21The approval of the European Community is valid in all EU member states, as well as in Iceland, Norway and Liechtenstein.
00:28Leo Pharma is the world leader in medical dermatology.
00:32The pathology we are talking about is an invalidating pathology, not only from a clinical point of view, but also for the psychological impact it can have.
00:41The research has led to a therapeutic solution that will be innovative and will try to satisfy that need that is still unsatisfied in the hand.
00:49The organ that is referred to as the skin is clearly a visible organ, so the life is not only professional, but also of a strongly impacted relationship.
00:59So any deviation from what is a healthy skin involves social, clinical and also, why not, expensive impacts in terms of expenses.
01:10Leo Pharma has always been committed to dermatology.
01:13Leo Pharma is a fairly young company in our country.
01:17About 12 years ago we founded Leo Pharma Italia, a company with a history of 108 years.
01:22108 years spent in this area of medicine, which are dermatological pathologies.
01:27We talked about chronic eczema of the hands, but there are others.
01:31We are committed to psoriasis and atopic dermatitis.
01:34We are also pushing to look for solutions in rare diseases.
01:38And we want to be a reference point for dermatologists.
01:41We have been in the past, we are now and we will be in the future.
01:45So a reference point for this specialty.
01:49Chronic eczema of the hands is in fact an inflammatory skin disease with different causes.
01:54It is characterized by a most chronic, recidivating clinical course and by the presence of subjective symptoms such as pruritus and severe pain.
02:02It manifests itself on hands and wrists with lesions such as erythema, edema and vesicles in the acute phase.
02:08And squamation, lichenification, hyperkeratosis and rickets in the chronic phase with serious consequences.
02:14Emphasizes Professor Luca Stingeni, Director of the Complex Structure of Dermatology of the Department of Medicine and Surgery of the Santa Maria della Misericordia Hospital of Perugia on the quality of life of those who suffer from it.
02:2670% of individuals affected by chronic eczema of the hands, in fact, refers to difficulties in the performance of daily activities and serious repercussions on their work activities due to the pathology.
02:39Thanks to this new drug, however, something has changed.
02:42But what is it about? How does it work? And what benefits does it give?
02:46Bucidinib is a molecule that will mark an important turning point in the treatment of patients affected by chronic eczema of the hands.
02:56Because it is a drug with a mechanism that we call JAKSTAT, that is, a mechanism of transduction of the inflammatory signal.
03:06Which blocks many of the mechanisms that then lead to the production of these inflammatory molecules, which are directly responsible for damage to the skin level.
03:19The bucidinib, being a pan-JAKSTAT, acts on many mechanisms that then lead to the formation of these inflammatory signals on different aspects of our immunity.
03:31This is the reason why the drug, in Phase 1 and 2 studies, conducted in 16 weeks, but also in the longest study, 32 weeks,
03:43and the results of the Phase 3 studies, in 16 weeks, were recently published on Lancet.
03:53Indeed, I am honored to be one of the authors of this article.
03:58They have shown the achievement of all the endpoints that appeared among the primary objectives of the study.