Pharmaceutical Market Europe • October 2023 • 8-9
NEWS
CSL Seqirus has unveiled new data highlighting the potential impact of influenza vaccines on reducing the burden that seasonal flu has on hospitals and broader healthcare systems.
Although most people can recover from the flu without requiring medical attention, the infection can cause severe illness among high-risk groups, including older adults.
In France, approximately two to six million people are affected by influenza every year, leading to over 20,000 hospitalisations and 10,000 excess deaths, 90% of which occur in older adults.
According to findings from a dynamic transmission model, standard-dose quadrivalent flu vaccines for older adults could reduce hospitalisations by 11.1-30.0% and cut ICU admissions by 9.7-28.7%. Additionally, enhanced vaccines for older adults are projected to further reduce the strain on hospital beds by 10-15%.
An analysis was also conducted in Belgium, where approximately 62% of older adults received a standard-dose egg-based influenza vaccine between 2015 and 2019, to evaluate the impact of using an adjuvanted quadrivalent influenza vaccine (aQIV).
Findings from the analysis highlighted that transitioning to aQIV would not only be cost-effective, but could prevent more than 6,900 influenza infections a year that would typically require medical care, along with 530 hospitalisations and 66 deaths.
The US Food and Drug Administration (FDA) has increased its collaboration with cancer drug manufacturers in a bid to overcome the country’s ongoing drug shortage problem and reduce its impact on patients.
The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their supply in the US has nearly halved in the past year.
To help alleviate the shortages of carboplatin and cisplatin, the FDA has been working closely with manufacturers to identify opportunities to increase manufacturing capacity and bring companies that have stopped producing those drugs back to the US market.
Additionally, the agency ‘exercised enforcement discretion’ for a manufacturer to import 14 lots of cisplatin from an FDA-registered facility outside the US.
These actions have restored the cisplatin supply to nearly 100% of the pre-shortage levels and are reportedly significantly relieving the shortages of carboplatin.
The FDA also boosted its collaboration channels with the five manufacturers of generic methotrexate for injection to help increase supplies.
Despite the progress, the Biden-Harris administration has emphasised that “there is more work to do”.
The UK is set to rejoin the Horizon Europe research initiative through a bespoke agreement with the EU.
The deal will create and support thousands of new jobs, support Prime Minister Rishi Sunak’s ambition to grow the economy and secure the UK as a ‘science and technology superpower’ by 2030.
Following a discussion with EU Commission President, Ursula Von der Leyen, Sunak secured improved financial terms of association with Horizon Europe that work for the UK and increase the benefits to UK scientists.
The UK will now participate as a fully associated member for the rest of the programme, which ends in 2027.
As part of the agreement, UK scientists will gain access to Horizon Europe and will benefit from cooperation with the EU, Norway, New Zealand and Israel, along with other countries that plan to join the programme, such as Korea and Canada.
Horizon will provide UK companies and research institutions with opportunities to lead global work to develop new technologies and research projects in areas including health and artificial intelligence.
Additionally, the UK will associate with Copernicus, the European Earth Observation programme, to provide the UK’s earth observation sector with access to unique data and the ability to bid for contracts.
Scientists at the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology (MIT) have discovered a potential new Alzheimer’s disease treatment that has been shown to reduce inflammation and improve memory.
Funded by the Robert A and Renee E Belfer Family Foundation and the National Institutes of Health, the scientists found that the candidate, named A11, repressed harmful inflammatory responses of the brain’s immune cells.
After comparing the gene expression of immune cells in post-mortem brain samples from Alzheimer’s patients and mouse models, the researchers found that the disease caused major changes in microglial gene expression and that PU.1 binding to inflammatory gene targets was a significant part of that change.
The researchers found that A11 suppressed PU.1 activity by recruiting other proteins that repressed the inflammatory genes that PU.1 works to express, without disrupting its other role.
They found that A11-treated cells exposed to inflammatory triggers behaved like unperturbed microglia, suggesting that A11 helps to prevent microglia from overreacting to inflammatory cues.
Pharmacological mouse tests also indicated that A11 was cleared from tissues and capable of reaching brain cells after the chemical successfully crossed the blood-brain barrier and remained in brain cells much longer than anywhere else in healthy mice.
Bristol Myers Squibb (BMS) has shared six-year follow-up results from a late-stage study of Opdivo (nivolumab) plus Yervoy (ipilimumab) in certain lung cancer patients.
The phase 3 CheckMate-227 trial has been evaluating the dual immunotherapy-based combination compared to chemotherapy as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC), regardless of their PD-L1 expression levels.
According to the results, which were presented at the IASLC 2023 World Conference on Lung Cancer, the combination continued to demonstrate long-term and durable survival benefits.
In patients with tumour PD-L1 expression levels of 1% and more – the primary endpoint population – the six-year survival rate for Opdivo plus Yervoy was 22%, compared to 13% for chemotherapy alone.
Additionally, an exploratory analysis of those with PD-L1 expression levels of less than 1% showed that more than three times as many patients treated with the Opdivo regimen survived at six years, compared to the chemotherapy group.
The safety profile for the combination remained consistent with previously reported data from the trial, BMS said, with no new safety signals observed.
Opdivo plus Yervoy-based combinations have also shown significant overall survival benefits in metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and oesophageal squamous cell carcinoma.
Eli Lilly is suing ten medical spas, wellness centres and compounding pharmacies to prevent the ‘unlawful marketing and sales’ of products fraudulently claiming to be Mounjaro (tirzepatide).
Lilly said that it cannot validate the safety and effectiveness of products claiming to contain tirzepatide that are not branded by the company.
In four lawsuits filed in Florida and Texas federal courts, Lilly is seeking an order barring Better Life Pharmacy, ReviveRX, Rx Compound Store and Wells Pharmacy Network from selling tirzepatide, and has requested unspecified damages for violating federal and state consumer protection and competition laws.
Similarly, the drugmaker is also seeking injunctive orders and damages against six medical spas and wellness centres from federal courts in Arizona, Florida, Georgia, South Carolina and Utah, claiming they infringe on its trademark by advertising compounded tirzepatide as Mounjaro.
In a statement, Lilly said: “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.”
Mounjaro, approved for type 2 diabetes, is only available from and manufactured by Lilly and is only commercially available in a pre-filled single-dose pen.