Monday, July 15, 2024

Eczema Treatment Gains NICE Backing for Almirall’s Monthly Drug

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Eczema patients in England can now be prescribed Almirall’s Ebglyss (lebrikizumab), offering them a therapy that requires only a once-a-month injection following NHS England’s approval. This approval follows the National Institute for Health and Care Excellence (NICE) recommending Ebglyss for patients aged 12 and over with moderate-to-severe atopic dermatitis, particularly for those who have not responded to at least one systemic immunosuppressant treatment or for whom such treatments are unsuitable. The UK drugs regulator had already approved this indication in December.

Ebglyss will enter the UK market as a competitor to existing treatments like Sanofi and Regeneron’s IL-4 and IL-13 inhibitor Dupixent (dupilumab), which was approved for eczema in 2018 and requires biweekly dosing. Ebglyss, on the other hand, is administered twice weekly during the first month, followed by a monthly injection for those who respond positively to the treatment.

Eczema Treatment Endorsed by BAD as Key Alternative to Existing Biologics

The British Association of Dermatologists (BAD) supported the drug during NICE’s appraisal process, highlighting its importance as an alternative to currently available biologics such as Dupixent and Leo Pharma’s IL-13 inhibitor Adtralza (tralokinumab), as well as various JAK inhibitors used for moderate-to-severe eczema.

Clinical trials have demonstrated that Ebglyss provides durable efficacy, with 80% of patients who responded to treatment at week 16 maintaining skin clearance and itch relief for one year of maintenance treatment. This represents a significant improvement in the management of eczema, a condition characterized by itchy, sore, cracked, and bleeding skin, which significantly impacts patients’ daily lives.

Andrew Proctor, chief executive of the National Eczema Society, emphasized the widespread yet often underestimated impact of eczema on patients and their families. He noted the condition’s influence on daily activities, clothing choices, and the need for time-consuming skincare regimens. Proctor stressed the importance of having a range of treatment options to cater to individual patient needs effectively.

Almirall has identified Ebglyss as its most significant new product launch in years, citing its good safety profile, including a low incidence of conjunctivitis, a common side effect of Dupixent. This positions Ebglyss as a strong competitor in the atopic dermatitis treatment market.

eczema

Eczema Drug Ebglyss Gains UK and EU Approval, Faces FDA Denial in the US

In addition to its UK approval, Ebglyss has been approved in the European Union. However, its approval in the United States, where Eli Lilly holds the rights, was denied by the FDA due to compliance issues at a third-party manufacturer. Analysts at Evaluate have projected that Ebglyss could become a $1.5 billion-a-year product, which would significantly enhance Almirall’s financial standing, considering the company reported total revenues of just under $1 billion last year.

The introduction of Ebglyss offers a new, less frequent dosing regimen that could improve adherence and quality of life for patients with moderate-to-severe eczema. The monthly injection schedule represents a significant advancement over the biweekly dosing required by Dupixent, making treatment more convenient and potentially more manageable for patients. Moreover, the availability of Ebglyss expands the therapeutic options for dermatologists and patients, providing an additional choice that may better suit the needs of certain individuals, particularly those who have not had success with other treatments.

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The NICE recommendation for Almirall’s Ebglyss marks a significant development in the treatment landscape for eczema in the UK. With its monthly dosing schedule, demonstrated efficacy, and favorable safety profile, Ebglyss is poised to become a valuable option for patients and healthcare providers. As Almirall prepares for the UK market launch, the potential impact on patient care and the company’s financial performance is substantial, underscoring the importance of this new therapeutic option in managing atopic dermatitis.

 

Resource: Almirall, July 10, 2024

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