Pharmaceutical Market Europe • January 2023 • 8-9

NEWS

European Commission approves Takeda’s dengue vaccine

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The European Commission (EC) has approved Takeda’s dengue vaccine candidate, Qdenga (TAK-003), to be used to prevent dengue fever in those aged four years and over, the company announced.

The decision makes Qdenga the only dengue vaccine approved for use in the EU regardless of whether recipients have previously been exposed to dengue fever.

The worldwide incidence of dengue fever, a mosquito-borne viral disease, has grown dramatically in recent decades. The vast majority of cases are asymptomatic or mild and self-managed, and therefore the actual numbers of dengue cases are under-reported. Many cases are also misdiagnosed as other febrile illnesses.

The EC’s approval, which follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in October 2022, was supported by results from 19 trials that included more than 28,000 children and adults.

This included four and a half years of follow-up data from the global pivotal phase 2 Tetravalent Immunization against Dengue Efficacy Study (TIDES) that showed that throughout the duration of the follow-up, Qdenga prevented 84% of hospitalised dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.


Sanofi/Regeneron’s Dupixent recommended for eosinophilic oesophagitis

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Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to treat adults and adolescent patients with eosinophilic oesophagitis (EoE).

The recommendation is for patients who are 12 years of age and older, weigh more than 40kg and are inadequately controlled by, are intolerant to, or are not candidates for conventional medicinal therapy.

Dupixent has already been approved to treat this patient group in the US, with a final decision expected from the European Commission within the coming months.

The CHMP’s decision was supported by a year’s worth of data from a phase 3 trial that showed that patients’ ability to swallow improved after just four weeks of being treated with Dupixent.

The study also demonstrated histological disease remission, improvements in abnormal endoscopic findings of the oesophagus and cellular improvements after 24 weeks compared to placebo, with outcomes maintained for up to a year.

To date, the treatment has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE or prurigo nodularis.


Merck and Moderna develop personalised cancer vaccine

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Merck & Co – known as MSD outside the US and Canada – and Moderna have announced positive results for their personalised mRNA cancer vaccine, mRNA-4157/V940, when used in combination with Merck’s Keytruda to treat patients with high-risk melanoma.

Personalised cancer vaccines are designed to prime the immune system to help patients generate tailored anti-tumour responses as part of their cancer treatment.

The phase 2b trial met its primary endpoint of recurrence-free survival, with the combination treatment reducing the risk of recurrence or death by 44% compared to Merck’s anti-PD-1 therapy alone.

In the ongoing KEYNOTE-942 trial, patients who had had surgery to remove their melanoma randomly received either mRNA-4157/V940 and Keytruda or only Keytruda for approximately one year until disease recurrence or unacceptable toxicity.

In October 2022, the companies announced that Merck had exercised its option to jointly develop and commercialise mRNA-4157/V940 in accordance with the terms of its existing collaboration and licence agreement.

Under the agreement, originally established in 2016 and amended in 2018, Moderna would receive an upfront payment of $250m from Merck, with the two companies sharing the costs and any profits equally under this worldwide collaboration.


WHO issues report on bacterial antimicrobial resistance

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The World Health Organization (WHO) has shared a new report – the Global Antimicrobial Resistance and Use Surveillance System (GLASS) Report – detailing evidence of high levels of resistance in bacteria, leading to life-threatening bloodstream infections.

WHO also found patterns of increasing resistance to treatment in several bacteria-causing common infections in the community, based on data provided by 87 countries in 2020.

The findings are significant as for the first time the GLASS report provides analyses for antimicrobial resistance (AMR) rates in the context of national testing coverage, as well as AMR trends since 2017 and data on human antimicrobial use in 27 countries.

In a six-year time frame, the report included data from 127 countries, covering 72% of the world’s population.

Dr Tedros Adhanom Ghebreyesus, WHO director-general, said: “To truly understand the extent of the global threat and mount an effective public health response to AMR, we must scale up microbiology testing and provide quality-assured data across all countries, not just wealthier ones.”

As a result of the pandemic, many countries were unable to provide data for 2020, and further research is required to determine the reasons behind the reported AMR increase, with more in-depth analysis needed about hospitalisation increases and antibiotic use during the COVID-19 pandemic.


Genomics England given £175m for genomics research

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Genomics England will lead three initiatives to improve genomic healthcare for patients, following the announcement of a £175m funding boost from the UK government.

The funding, which is part of a three-year plan to accelerate new technologies across the UK health and care system and life sciences sector, could allow children born with treatable rare genetic diseases and patients with cancer to benefit from earlier diagnosis and faster access to treatment.

Two of the initiatives will be conducted in partnership with the NHS, including a research study exploring the effectiveness of using whole genome sequencing to find and treat rare genetic diseases in newborn babies, as well as an innovative cancer programme evaluating genomic sequencing technology to improve the accuracy and speed of diagnosis for cancer patients.

Currently, the NHS heel prick blood test is used to detect nine rare and serious health conditions in babies, but screening babies’ entire genome alongside this could detect hundreds more rare, treatable diseases.

Another Genomics England-led programme will focus on genome sequencing of around 25,000 research participants of non-European ancestry who are currently under-represented in genomic research, to improve understanding of DNA and its impact on health outcomes.


ICR and University of Cambridge reveal new prostate cancer prediction tool

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Researchers from the The Institute of Cancer Research, London (ICR) and the University of Cambridge have revealed a newly created comprehensive tool, CanRisk-Prostate, for predicting the risk of developing prostate cancer.

The scientists involved have said the tool will ensure that men who have a higher chance of developing prostate cancer will be offered appropriate testing, and that potentially invasive testing for those at a very low risk will also be reduced.

CanRisk-Prostate will be incorporated into the group’s established CanRisk web tool, which is already used globally by healthcare professionals to help to predict the risk of breast and ovarian cancers.

Scientists involved in the tool’s creation produced the first comprehensive prostate cancer model, which uses genetic and cancer family history data from almost 17,000 families impacted by the disease.

The new study describing the model has been published in the Journal of Clinical Oncology.

Researchers anticipate that clinicians will be able to use any combination of cancer family history, and rare and common genetic variants, to offer a tailored risk prediction.

The Early Detection and Diagnosis centre at the ICR and The Royal Marsden NHS Foundation Trust have established a prostate risk clinic to use the results to create targeted screening programmes for those who may be at risk.