Pharmaceutical Market Europe • June 2023 • 8-9

NEWS

GSK’s RSV vaccine approved by FDA for older adults

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GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older.

The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world.

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease.

The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older – the trial’s primary endpoint.

Positive vaccine efficacy was also observed in those with comorbidities of interest, such as certain cardiorespiratory conditions, underlining the potential impact of the candidate on populations most at risk of severe RSV outcomes.

The Advisory Committee on Immunization Practices will make recommendations in June on the appropriate use of the vaccine, which is expected to be available for older adults in the US before the 2023/24 RSV season.

The approval came less than a week after the European Medicines Agency’s human medicines committee recommended the vaccine for the same patient population.


AbbVie’s Rinvoq receives FDA approval for Crohn’s disease

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AbbVie’s Rinvoq (upadacitinib) has been approved by the US Food and Drug Administration (FDA) as a treatment option for adults with moderately to severely active Crohn’s disease.

The authorisation specifically applies to patients who have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.

Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain.

Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery.

The FDA’s decision was supported by data from three phase 3 trials, including two induction studies and one maintenance study.

Across all three studies, significantly more Rinvoq-treated patients achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).

Additionally, a higher proportion of patients receiving a once-daily 45mg dose of Rinvoq at week 12 in the induction studies or 15mg and 30mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per SF/AP compared to placebo.


UK life sciences sector to receive £650m in government funding

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The UK government has announced a £650m funding package to support the continued growth of the life sciences sector.

Unveiled by chancellor Jeremy Hunt, the ‘life sci for growth’ package includes £121m to speed up clinical trials, as well as £48m to support scientific innovation in preparing for potential health emergencies.

Another £154m has been committed to increase the capacity of the UK Biobank. This funding will go towards a new facility at Manchester Science Park, a new hub to help small-to-medium-sized enterprises collaborate with industry and academia, and better IT to accommodate multi-disciplinary data.

A new call for proposals has also been released as part of the initiative that will offer £250m to incentivise pension schemes to invest in the UK’s science and technology businesses.

The package also include plans to relaunch the Academic Health Science Network as Health Innovation Networks in a bid to boost innovation and unify the NHS, local communities, charities, academia and industry to share best practice.

Changes to planning rules to free up lab space are also included, as well as updates to a route for East West Rail – the new railway line – to improve connections between Oxford and Cambridge and bring more investment to the region.


WHO report shows progress as well as gaps in AMR antibiotic pipeline

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The World Health Organization (WHO) has released a new report considering how global health systems can stimulate the research and development (R&D) of new antibiotics to ‘combat’ antimicrobial resistance (AMR), which has been declared by the organisation as one of the top ten threats to global health.

The report, Incentivising the development of new antibacterial treatments 2023, was developed in partnership with the Global AMR R&D Hub and highlights the ‘substantial progress’ that has been made by G7 countries to support R&D into new antibiotics, but also the remaining gaps in ensuring a robust pipeline of treatments.

WHO said in a statement: “Current efforts remain insufficient to address the antibiotic pipeline and access crisis. In particular, efforts to ensure equitable access to antibiotics in low- and middle-income countries that experience the highest burden of AMR, are lacking.”

The G7 has already committed to a joint agreement on AMR and made a political commitment to action. The new report from WHO proposes a set of priority actions to accelerate progress over the next two years, including working towards these targets for the high-level meeting on AMR at the United Nations General Assembly next year, as well as increasing equitable and global access to antibiotics.


NHS to introduce world-first genetic blood-matching test

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The NHS is set to become the first healthcare system in the world to provide blood group genotyping tests to assist thousands that suffer from blood disorders.

Delivered in partnership by NHS England and NHS Blood and Transplant (NHSBT), the new programme could reduce the painful side effects of blood transfusion treatments that are needed for different conditions.

Sickle cell disease triggers intense pain when red blood cells block vessels and restrict oxygen supply. In England, around 17,000 people live with the disease.

Affecting around 800 patients in England, thalassaemia is an inherited blood disorder that produces a lack of haemoglobin, used by red blood cells to carry oxygen around the body.

For both conditions, blood transfusions are the most common treatment. However, 17% of patients experience painful side effects after transfusion due to inadequately matched blood, leading to reactions that can be severe or fatal.

The new programme will provide DNA analysis of patients’ blood groups and will assist in being able to more accurately match blood types to those in need of donated blood transfusions.

The £1m funding provided by NHS England for NHSBT will be used to provide blood group genotyping in its specialised molecular diagnostics laboratory and develop a donor database.


Researchers at ICR London discover new nutrient source for cancer growth

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Researchers at the Institute of Cancer Research (ICR), London and the University of Michigan in the US have announced a discovery about the changing ‘diet’ within pancreatic cancer cells that enables them to grow.

The findings were published in Nature and funded by Pancreatic Cancer UK, the Ian Harty Charitable Trust and the National Institutes of Health (NIH) in the US.

The newly discovered nutrient source, uridine, is a molecule that replaces glucose in pancreatic cancer cells to adapt as a fuel source, and could lead to a new treatment strategy for this aggressive cancer. Researchers believe that uridine could also help fuel other cancers including lung, stomach and brain cancer.

Phenotypic microarray, a new technique that allows the simultaneous testing of thousands of cell characteristics, was used by researchers to discover that uridine is broken down by the enzyme, uridine phosphorylase-1 (UPP1), to produce a new form of sugar, ribose, which can fuel cancer cells.

Team leader in systems and precision cancer medicine at the ICR, London, Dr Anguraj Sadanandam, said: “Next, we will explore ways to use uridine to monitor existing therapy responses in pancreatic cancer and hopefully develop new drugs targeting UPP1.”