Pfizer’s Litfulo (ritlecitinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat severe alopecia areata in patients aged 12 years and older.

Affecting approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face or body.

Litfulo, which is a once-daily oral kinase inhibitor, works by blocking the activity of enzymes in the body involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

The MHRA’s decision on the drug was supported by positive results from the phase 2b/3 ALLEGRO trial, which evaluated Litfulo in patients aged 12 years and older with 50% or more scalp hair loss, including those with total scalp and body hair loss.

Results showed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo 50mg compared to 1.5% in the placebo group.

The drug is also being evaluated in the ongoing phase 3 ALLEGRO-LT study, with safety and efficacy data being collected for adults with 25% or greater scalp hair loss and adolescents aged 12 years and older with 50% or greater scalp hair loss.

Almirall has announced that its IL-13 inhibitor Ebglyss (lebrikizumab) has been approved by the European Commission (EC) to treat moderate-to-severe atopic dermatitis.

The regulator has specifically approved the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy.

An estimated 4.4% of adults in the EU are affected by atopic dermatitis, a chronic, inflammatory disease of the skin characterised by recurrent inflammation associated with intense pruritus.

The EC’s decision was supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in patients with moderate-to-severe atopic dermatitis, as well as data from the phase 3 ADhere study assessing the drug in combination with topical corticosteroids.

At week 16, almost 60% of patients experienced at least a 75% reduction in disease severity when receiving Ebglyss monotherapy, and nearly 70% of those receiving Ebglyss combined with standard-of-care topical corticosteroids achieved the 75% reduction.

Almirall has licensed the rights to develop and commercialise Ebglyss for use as a treatment for dermatology indications in Europe, while Eli Lilly has exclusive rights for the development and commercialisation of the drug in the US and the rest of the world.

In observance of this year’s World Psoriasis Day on 29 October, Almirall highlighted the major impact the disease can have on the well-being of patients.

An estimated 60 million people worldwide are affected by psoriasis and up to 90% of patients have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales.

Beyond its physical symptoms, almost 77% of patients believe that psoriasis negatively affects their normal daily activities and well-being and, according to the International Federation of Psoriatic Disease Associations, 80% have reported that the condition has affected their relationships and family life.

Recent findings of a study conducted by Almirall have also shown that the well-being of patients with moderate-to-severe plaque psoriasis was comparable to the level found in other diseases such as breast cancer or diabetes.

Dr Volker Koscielny, chief medical officer at Almirall, said: “We know that psoriasis affects more than just the skin and has a significant impact on the quality of life of people living with it.

“At Almirall, we have taken a step further and measured for the first time how this disease affects not only the patients, but also their families, relatives and even their physicians.”

Almirall and Absci have announced a drug discovery partnership aimed at developing and commercialising artificial intelligence (AI)-designed treatments for dermatological diseases, with the deal worth over $650m.

The collaboration will combine Almirall’s dermatological capabilities with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”.

Under the terms of the agreement, Absci will apply its de novo generative AI technology to create and commercialise therapeutic candidates for two dermatological targets.

In addition to product royalties, Absci is eligible to receive up to approximately $650m in upfront fees, research and development (R&D) and post-approval milestone payments across the two programmes if all milestones are successfully completed.

Dr Karl Ziegelbauer, Almirall’s executive vice president of R&D and chief scientific officer, said: “Almirall chose Absci because [its] de novo platform brings truly novel innovation in solving the industry’s most challenging targets facing high unmet medical need.”

The collaboration represents Almirall’s first de novo AI drug collaboration and marks an expansion to Absci’s de novo AI drug creation portfolio into dermatology, the companies outlined.

LEO Pharma has announced positive results from an open-label extension study of its investigational JAK-inhibtor cream delgocitinib in adults with moderate-to-severe chronic hand eczema (CHE).

The late-stage DELTA 3 trial enrolled patients who had completed the 16-week twice-daily treatment regimen of delgocitinib or vehicle cream in the phase 3 DELTA 1 or DELTA 2 trials.

Results showed that the safety profile of twice-daily treatment with delgocitinib cream for up to 36 weeks was consistent with previous results from DELTA 1 and 2.

Additionally, patients who entered DELTA 3 after receiving delgocitinib cream in DELTA 1 and 2 maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen, LEO said, and those who had received vehicle cream reached similar levels of treatment success as the patients previously treated with delgocitinib.

CHE, which affects a substantial number of patients, is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.

The company outlined that further analysis of the data from DELTA 3 will be conducted to “determine the full potential of delgocitinib cream” in this patient population, with detailed results from the trial set to be submitted for scientific presentation and publication at a later date.