The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Amryt Pharmaceuticals’ Filsuvez (birch bark extract) for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa (EB).

Affecting around 500,000 people worldwide, EB is a rare inherited skin disorder that causes the skin to become fragile, causing blisters, tears and the loss of skin segments.

NICE’s decision, which is expected to benefit around 670 patients in England, marks the first time the institute has recommended an EB treatment.

The recommendation follows positive results from the phase 3 birch bark extract clinical trial, EASE, which found that the treatment led to quicker wound healing in patients with dystrophic and junctional EB and had potential to reduce the amount of skin affected.

The EASE trial was the largest phase 3 randomised control trial to examine the efficacy and safety of Amryt’s Filsuvez gel/Oleogel-S10 in comparison to the control gel for EB.

Patients with EB from the EASE double-blind phase who received the treatment experienced a reduction in overall wound burdens, a reduced frequency of dressing changes, and were well tolerated, with a similar safety profile to control gel.

Bristol Myers Squibb’s Opdivo (nivolumab) has been approved by the European Commission (EC) as an adjuvant treatment in adults and adolescents with completely resected stage 2B or 2C melanoma.

The decision makes Opdivo, which is already approved in the EU for use in certain melanoma patients, the only PD-1 inhibitor authorised as an adjuvant treatment for patients within stages 2B, 2C and 3, as well as stage 4 resected melanoma.

The incidence of melanoma has been rising steadily over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses.

Opdivo is a PD-1 immune checkpoint inhibitor that is designed to utilise the body’s own immune system to help restore an anti-tumour immune response.

The EC’s latest approval for the therapy, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, was supported by positive safety and efficacy results from the phase 3 CheckMate-76K trial, in which the therapy reduced the risk of recurrence or death by 58% versus placebo at a minimum follow-up of 7.8 months.

Novartis has shared positive top-line results from two late-stage studies evaluating its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.

Affecting approximately 40 million people worldwide, CSU is a debilitating and unpredictable condition characterised by the occurrence of itchy hives and/or deep tissue swelling that lasts for six weeks or longer.

H1-antihistamines are the first-line treatment for the condition; however, approximately 60% of patients are inadequately controlled by these alone and continue to live with the distressing symptoms of CSU.

Novartis’ remibrutinib works by blocking the cascade of BTK, an enzyme central to the release of histamine and, when spontaneously activated, plays a critical role in the symptoms associated with CSU.

The ongoing phase 3 REMIX-1 and REMIX-2 trials met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity.

Remibrutinib also demonstrated a rapid onset of action as shown by the improvement of UAS7 at week two, Novartis said, adding that the therapy was well tolerated and demonstrated a favourable safety profile.

AbbVie has announced that the first patient has been dosed in a late-stage study of its selective JAK inhibitor, Rinvoq (upadacitinib), in adults and adolescents with moderate-to-severe hidradenitis suppurativa (HS).

An estimated 1% of the global population is affected by HS, but patients can experience increasing disease severity and symptoms for as long as ten years before receiving an accurate diagnosis.

AbbVie’s phase 3 Step-Up HS trial will aim to enrol about 1,300 patients who have failed anti-TNF therapy and/or one approved non-anti-TNF inhibitor therapy for the condition. These patients will be randomised to receive Rinvoq or placebo.

The study’s primary endpoint will measure the percentage of patients achieving at least a 50% reduction in the total abscess and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 16.

The launch follows the completion of a mid-stage study of Rinvoq in patients with moderate-to-severe HS.

The results, which were presented at this year’s American Academy of Dermatology Annual Meeting in March, showed that a higher proportion of Rinvoq-treated patients achieved at least a 50% reduction in abscess and inflammatory nodule count without an increase in abscess or draining fistula count compared to those receiving placebo.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved UCB’s Bimzelx (bimekizumab) as a treatment option for certain adults with psoriatic arthritis.

The marketing authorisation specifically applies to patients with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying anti-rheumatic drugs.

The MHRA’s decision, which indicates Bimzelx alone or in combination with methotrexate, was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations.

The approval is one of two new marketing authorisations granted to the inflammatory disease drug by the MHRA. The second applies to certain adults with active axial spondyloarthritis – a type of arthritis that mainly affects the joints of the spine.

Together, the authorisations make Bimzelx the first treatment approved for these two patient populations that is designed to inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory disease.

Claire Brading, managing director UK and Ireland at UCB, said the approvals marked a “significant milestone for the rheumatology community in the UK”.

Bimzelx is already approved in the UK to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.