The US Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi (minocycline hydrochloride extended release capsules 40mg) to treat inflammatory lesions of rosacea in adults.

The regulator’s decision on the drug, which Journey developed in collaboration with Dr Reddy’s Laboratories, was based on results from two 16-week phase 3 rosacea trials, which met all co-primary and secondary endpoints, with no significant safety issues observed.

The drug demonstrated statistically significant superiority over both Galderma’s standard-of-care Oracea 40mg capsules and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count.

Affecting more than 16 million people in the US, rosacea is a long-term inflammatory skin condition that causes deep facial redness, acne-like inflammatory lesions and visible blood vessels in the face.

Beyond its physical manifestations, psychological impact has been recognised as a significant part of rosacea, with 90% of patients in National Rosacea Society surveys reporting that the condition had lowered their self-confidence and self-esteem.

Journey anticipates that an initial supply of the drug will be available in the first or second quarter of 2025.

Johnson & Johnson (J&J) and Protagonist Therapeutics have announced positive top-line results from a late-stage study of their investigational targeted oral peptide in plaque psoriasis.

The phase 3 ICONIC-LEAD trial has been evaluating the candidate, icotrokinra (JNJ-2113), in adult and adolescent patients aged 12 years and older with moderate-to-severe cases of the immune-mediated disease.

Both co-primary endpoints of the study were met, with 64.7% of icotrokinra-treated patients achieving Investigator’s Global Assessment (IGA) scores of zero or one (clear/almost clear skin) and 49.6% achieving at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90) at week 16, compared to 8.3% and 4.4% of patients receiving placebo, respectively.

Increases in response rates continued to be demonstrated at week 24, with 74.1% of patients randomised to receive icotrokinra achieving IGA scores of zero or one, and 64.9% achieving PASI 90.

The companies also shared promising top-line results from the phase 3 ICONIC-TOTAL trial, in which icotrokinra met the primary endpoint of IGA scores of zero or one at week 16 compared to placebo.

Galderma’s nemolizumab has been shown to improve the core signs and symptoms of prurigo nodularis, according to phase 3 results published in JAMA Dermatology.

The 24-week OLYMPIA 1 trial evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe cases of the chronic skin condition.

The study met both its primary and all key secondary endpoints, and clinically meaningful responses in itch and sleep disturbance were observed from as early as week four.

After 16 weeks of treatment, 58.4% of patients randomised to receive nemolizumab achieved at least a four-point improvement in itch intensity compared to 16.7% of those in the placebo group.

Clearance or almost-clearance of skin lesions was achieved by 26.3% of nemolizumab-treated patients versus 7.3% of those in the placebo arm.

Prurigo nodularis is estimated to affect up to 181,000 people in the US and is characterised by intense itch and thick skin nodules covering large body areas.

The publication comes three months after nemolizumab was approved by the US Food and Drug Administration under the brand name Nemluvio to treat adults with prurigo nodularis.

GSK’s linerixibat has shown promising results in a late-stage trial of primary biliary cholangitis (PBC) patients with cholestatic pruritus, or relentless itch.

The phase 3 GLISTEN trial has been evaluating the candidate in adult PBC patients with moderate-to-severe itch who were receiving stable doses of guideline-suggested therapies for pruritus, were treatment naïve, or had been previously treated.

The study met its primary endpoint, with linerixibat demonstrating a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo.

The preliminary safety results were also found to be generally consistent with those seen in prior studies of the drug, GSK said, adding that full results of the trial will be presented at a future scientific congress.

Pruritus, which can occur at any stage of PBC, is experienced by up to 90% of patients and is associated with sleep disturbance, fatigue and impaired quality of life.

Linerixibat is designed to address a root cause of cholestatic pruritus by inhibiting bile acid re-uptake and has already been granted orphan drug designation by the US Food and Drug Administration and the European Medicines Agency.