Pharmaceutical Market Europe • November 2023 • 8-9
NEWS
Amgen has shared new findings from the phase 3 N-MOmentum clinical trial that offer insights on the peripheral presence of inflammatory biomarkers associated with neuromyelitis optica spectrum disorder (NMOSD) and reinforce the ‘durable impact’ of Uplizna (inebilizumab) in reducing disease-related attacks.
Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.
Uplizna is the only CD19-positive B-cell-depleting therapy approved in the US, Europe and other markets to treat NMOSD in adults who are AQP4-IgG positive.
A new analysis from N-MOmentum focuses on the relationship between levels of small signalling proteins called cytokines, which are associated with inflammation throughout the body, and disease activity in NMOSD.
It found significantly elevated levels in 18 of the 92 proteins in both treated and placebo group patients at baseline, most notably IL-17a, which was elevated in approximately 60% of patients.
Regardless of baseline cytokine levels, attack rates decreased among those who received Uplizna throughout the open-label period, Amgen said.
Additionally, using data from the trial’s open-label extension period, it was found that Uplizna significantly extended the time to onset of an NMOSD attack compared to reported data on immunosuppressive therapies or placebo.
The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring.
The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs.
The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”.
The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December.
Earlier this year, the FDA issued new draft guidance on the implementation of decentralised clinical trials, in which some or all trial-related activities occur at locations other than traditional investigation sites.
The guidance covers topics such as trial design, the use of DHTs for remote patient monitoring, and the roles and responsibilities of sponsors and investigators.
Over 20 life sciences leaders from companies supplying the NHS with essential medicines have united to warn against the ‘radical plans’ to change the statutory scheme for branded medicines.
The pharmaceutical industry believes that the changes to the medicines scheme are ‘unworkable’ and could be highly damaging to UK life sciences and NHS patient access to medicines if implemented.
One of several pricing mechanisms that control the NHS’s spending on branded medicines, the statutory scheme requires companies to pay back a percentage of their NHS-branded medicines sales to the Department of Health and Social Care (DHSC) above an arbitrary growth cap.
Additionally, an agreement between the UK government and a minority of companies, the voluntary scheme (VPAS), is due to end in December 2023. Without a new VPAS deal agreed upon, all sales of branded medicines will fall subject to the statutory scheme.
One of the main concerns for life sciences companies is the government’s continuation of an arbitrary growth cap on the UK branded medicines market.
The DHSC has also proposed a new Life Cycle Adjustment to maintain the total revenue raised through sales clawbacks by reducing rates paid by newer medicines and imposing higher rates of up to 40% on medicines older than 12 years.
UCB’s inflammatory disease drug Bimzelx has been approved by the US Food and Drug Administration (FDA) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
The decision makes Bimzelx the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes.
More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system.
Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales.
The FDA’s approval was supported by data from three late-stage trials in which patients treated with Bimzelx achieved superior levels of skin clearance after 16 weeks of treatment compared to those who received ustekinumab, placebo or adalimuma.
More than 80% of patients receiving Bimzelx achieved clear or almost clear skin at week 16 and approximately 60% achieved complete skin clearance.
Clinical responses reached with Bimzelx at week 16 were also maintained for up to one year, UCB said, adding that long-term data showed that clinical responses were maintained in the vast majority of patients through three years of treatment.
A new study by the European Academy of Dermatology and Venereology (EADV) has revealed how stigmatisation has a psychological impact on individuals living with skin conditions across Europe.
Published in the Journal of the European Academy of Dermatology and Venereology, the study analysed more than 19,000 individuals across 27 European countries living with a range of skin conditions, including acne, atopic dermatitis and psoriasis.
The study, The Burden of Skin Disease in Europe, analysed individuals’ journeys from medical consultations to diagnosis, as well as their reasons for not consulting a healthcare professional. The study found that 88% of patients said that their condition was ‘embarrassing’ in their personal lives.
Similarly, 83% reported the same in their working lives, which led to around 25% of patients reporting having changed their professional activity because of their condition.
In particular, individuals living with acne (48%) and urticaria (60%) were most impaired in their work lives.
Almost half of the adult European population had already declared that they had at least one dermatological condition, according to previous findings from the study.
Skin conditions receive limited policy, research and funding attention, particularly as many individuals avoid medical consultations, which ultimately contributes to an underestimated prevalence.
Novartis’ Cosentyx (secukinumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adults in England and Wales with active moderate-to-severe hidradenitis suppurativa (HS).
The recommendation, which makes Cosentyx the first biologic treatment for HS since 2016, specifically applies to patients who have had an inadequate response to conventional systemic HS therapy and where adalimumab is not suitable, did not work or has stopped working.
Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and severe plaque psoriasis, Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in inflammation.
The final draft guidance is supported by results from two identical late-stage trials, in which Cosentyx continued to improve response rates beyond the primary endpoint analysis at week 16 to more than 55% of patients achieving an HS clinical response measure at week 52.
Additionally, approximately 50% of Cosentyx-treated patients had a meaningful reduction in HS-related pain at week 52.
Novartis said it has an agreement with NHS England to enable eligible HS patients to obtain immediate access to Cosentyx through the interim Innovative Medicines Fund, which provides funding to accelerate NICE-recommended non-cancer medicines into the NHS.