Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA) to treat adults with bullous pemphigoid (BP).

BP is a relapsing skin disease that mainly affects older adults and is characterised by intense itch, blisters and painful lesions.

Already approved for a range of indications, Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases.

If authorised for this latest indication, Dupixent would be the first targeted medicine to treat BP in the US.

The companies’ supplemental biologics licence application for the drug was supported by the phase 2/3 ADEPT trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP.

The study met its primary endpoint, with five times more Dupixent-treated patients achieving sustained disease remission compared to those receiving placebo. Dupixent was also shown to significantly reduce disease severity, itch and oral corticosteroids use compared to placebo.

Recce Pharmaceuticals has shared positive data from a phase 2 study of its RECCE 327 topical gel (R327G) in acute bacterial skin and skin structure infections (ABSSSIs).

The trial has been evaluating the safety and efficacy of the candidate when applied directly to the infected area in adults with ABSSSIs, including those with diabetic foot infections (DFIs).

ABSSSIs, including DFIs and post-operative wound infections, are considered a significant healthcare concern, and there is a demand from the US Food and Drug Administration for new broad-spectrum antibiotics to address antimicrobial resistance, which has been declared by the World Health Organization as one of the top ten threats to global health.

After seven days of treatment, 86% of R327G-treated patients had a successful clinical response and, after 14 days, 93% achieved a primary efficacy endpoint.

R327G was also shown to be safe and well tolerated, with no serious adverse events reported.

Recce said the data confirms the approach for its approved registrational phase 3 DFIs study in Indonesia, adding that it is expecting to initiate a registrational phase 3 trial in Australia for ABSSSIs and DFIs.

Bristol Myers Squibb (BMS) has shared positive five-year results from a long-term extension (LTE) study of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in adults with moderate-to-severe plaque psoriasis.

The POETYK PSO LTE enrolled patients who completed the 52-week phase 3 POETYK PSO-1 and POETYK PSO-2 trials to receive a once-daily dose of Sotyktu, which is already approved in major markets to treat certain patients with moderate-to-severe plaque psoriasis.

Plaque psoriasis occurs in up to 90% of psoriasis patients and is characterised by distinct round or oval plaques that are usually covered by silvery-white scales.

Results showed that clinical response rates were maintained in patients who were treated continuously with Sotyktu, with 46.3% achieving at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90) at year five compared to 45.9% at year one.

Additionally, 67.3% of patients achieved PASI 75 at year five compared to 72.1% at year one, and 52.6% achieved Physician’s Global Assessment scores of zero or one (clear/almost clear skin) after five years compared to 57.5% after one year.

The European Commission (EC) has approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.

Yesintek has been authorised to treat moderate-to-severe plaque psoriasis in adults and children aged six years and older whose condition has not improved with, or who are unable to use, other systemic treatments, as well as to treat active psoriatic arthritis in adults whose condition has not improved enough with disease-modifying anti-rheumatic drugs.

Plaque psoriasis occurs in up to 90% of psoriasis patients and is characterised by distinct plaques that are usually covered with silvery scales, while psoriatic arthritis, which causes joint pain, stiffness and swelling, affects up to 30% of psoriasis patients.

Ustekinumab is designed to block the activity of interleukin 12 and interleukin 23, which are thought to play an important role in inflammation.

The EC’s decision on Yesintek, which is also approved to treat certain cases of Crohn’s disease, follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by clinical data showing that Biocon’s drug has comparable safety and efficacy to Stelara.