Inside EU Health: Heat resilience; EMA recommendations; Sanofi disparagement
Europe’s deadly heatwave highlights growing climate threat to health; EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome; Commission opens disparagement investigation into Sanofi
Europe’s deadly heatwave highlights growing climate threat to health
Europe is once again grappling with an unprecedented heatwave, with extreme temperatures pushing health systems to the limit and claiming more than 1,300 excess lives since 21 June.
“Europe is the fastest-warming continent on Earth, heating at twice the global average," said World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus. “Heat stress is often called the ‘silent killer’ and European homes, workplaces and schools were not built for these temperatures.”
What was once considered a "once-in-a-generation" heatwave is now occurring almost every year, underscoring the accelerating impacts of global warming.
The DG said that the effects can be less visible but equally devastating, particularly for older adults, children, people with chronic illnesses and outdoor workers. European homes, workplaces and schools were largely designed for a cooler climate, leaving millions vulnerable as temperatures continue to rise.
The WHO is urging countries to strengthen their heat-health action plans through stronger political leadership, cross-sector coordination, and effective warning systems.
EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome
The European Medicines Agency’s human medicines committee (CHMP) has recommended the approval of six medicines, rejected three applications, and backed 13 extensions of existing therapeutic indications at its latest monthly meeting.
Among the approvals, CSL Seqirus received a positive opinion for Aujemflu, an influenza vaccine for adults aged 50 and over. The committee also endorsed Hopledo for Parkinson’s disease, Onswik, a once-weekly insulin for type 2 diabetes, and Daybu, the first recommended treatment in Europe for the neurobehavioural symptoms of Rett syndrome.
However, CHMP recommended revoking the marketing authorisation for Tavneos after concluding that data from its pivotal ADVOCATE study were inaccurate and breached good clinical practice. CSL Seqirus said it remains committed to supporting patients and advised those receiving the treatment to consult their physicians.
Catherine Feore
Commission opens disparagement investigation into Sanofi
The European Commission has opened a formal investigation into possible anticompetitive conduct by Sanofi for disparaging a competitor’s flu vaccine intended for vulnerable patient groups.
Sanofi’s ‘Efluelda’ and CSL Seqirus’s ‘Fluad’ enhanced flu vaccine are specifically designed to provide greater protection against influenza for people over 60.
The Commission claims that Sanofi pursued a misleading communication campaign targeting healthcare professionals in Germany and France, suggesting that the evidentiary basis for Fluad was weaker than for its vaccine. This contradicted the findings of the European Centre for Disease Control (ECDC) and national immunisation technical advisory groups in Germany and France.
Catherine Feore