Boehringer Ingelheim’s Spevigo (spesolimab) injection has been recommended by the European Medicines Agency’s human medicines committee for the prevention of generalised pustular psoriasis (GPP).

The Committee for Medicinal Products for Human Use has recommended approval of the injection to prevent GPP flares in adults and adolescents from 12 years, and has also recommended extended approval of Spevigo infusion to treat GPP flares in adults and adolescents from 12 years as a monotherapy.

Spevigo is designed to bind to the interleukin-36 receptor, a key part of a signalling pathway within the immune system shown to be associated with GPP.

The endorsements were based on positive results from the 48-week phase 2b EFFISAYIL 2 clinical trial, as part of the EFFISAYIL clinical programme combining EFFISAYIL 1, a phase 2 study, EFFISAYIL ON, an open-label extension study and the ongoing EFFISAYIL REP open-label, phase 3b/4 trial.

Results from the phase 2b trial showed that Spevigo significantly reduced the risk of GPP flares by 84% in 123 patients compared with placebo and no flare-ups were observed in patients from the high-dose group with Spevigo subcutaneous treatment after week four.

Bristol Myers Squibb (BMS) has announced that its immunotherapy combination, Opdualag (nivolumab-relatlimab), has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland for advanced melanoma.

Providing an additional treatment option for eligible patients living with the form of skin cancer, the first approved LAG-3 blocking antibody combination is indicated as a first-line treatment in adults and adolescents aged 12 years and older.

Currently the fifth-most common cancer in the UK, melanoma is a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably.

The condition affects more than 1,200 people in Scotland every year and approximately 10% of all cases in the UK are diagnosed at more advanced stages.

The SMC’s decision was based on results from the phase 2/3 RELATIVITY-047 trial, which has been evaluating Opdualag compared to nivolumab alone in 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma.

The trial achieved its primary endpoint after the combinative immunotherapy more than doubled median progression-free survival after a median follow-up of 19.3 months, compared to nivolumab monotherapy.

BioNTech has announced positive phase 2 results for its mRNA immunotherapy candidate in a subset of advanced melanoma patients.

The EudraCT clinical study has been evaluating BNT111 in combination with Regeneron’s PD-1 checkpoint inhibitor Libtayo (cemiplimab) in patients with stage 3 or 4 melanoma whose disease had progressed following anti-PD-L1-containing treatment.

Anti-PD-1 refractory/relapsed unresectable stage 3 or 4 melanoma, an aggressive form of the disease, has a particularly poor prognosis for patients.

The investigational mRNA immunotherapy is based on the company’s FixVac platform, which utilises a fixed combination of four mRNA-encoded, tumour-associated antigens designed to trigger an innate and tumour-antigen-specific immune response against cancer cells that express one or more of the respective tumour antigens and is delivered as a uridine mRNA-lipoplex formulation.

The ongoing EudraCT trial showed that BNT111 in combination with Libtayo demonstrated a statistically significant overall response in patients, meeting its primary efficacy outcome measure, and was well tolerated, with the safety profile of BNT111 in combination with Libtayo being consistent with previous clinical trials assessing BNT111 in combination with anti-PD-L1-containing treatments.

LEO Pharma, Allergy UK and the CHE Taskforce have published the results of a survey that revealed the real-life impacts and heavy burdens of chronic hand eczema (CHE) that patients experience.

The Chronic Hand Eczema Patient Impact Report was supported by LEO Pharma’s multidisciplinary taskforce, which comprises healthcare professionals (HCPs) with expertise in CHE.

Approximately 152 people aged 18 years and over in the UK who had experienced CHE for more than a year took part in a 15-minute online survey that focused on the physical experience and unavoidable triggers of CHE, its psychosocial impact, quality of life (QOL) and relationships, impact on work and education, and the patient healthcare experience.

The report revealed that CHE negatively affected QOL, work and relationships, with more than 50% of respondents reporting that they had experienced anxiety or anger due to CHE, while only 14% had been asked about the emotional impact of their CHE by an HCP.

In addition, around 50% of respondents said that their CHE influenced their career choice, while 72% stated that they currently experience some impact on their current work or education.

Almirall has announced that the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) to treat atopic dermatitis (AD).

The IL-13 inhibitor can now be used to treat moderate-to-severe AD in adults and adolescents aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy.

NICE’s decision follows the Medicines and Healthcare products Regulatory Agency’s approval of the therapy in December.

Ebglyss, which also received approval from the European Commission last year, represents “a step forward” for uncontrolled moderate-to-severe AD patients, Almirall said, citing the therapy’s selective mechanism of action, efficacy, safety profile and four-weekly maintenance dosing.

The approvals were supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy, 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 in the ADvocate studies and nearly 70% of those receiving the Ebglyss combination achieved the 75% reduction in ADhere.