New Antifungal, H5N1 Vigilance, and Psilocybin's Six-Month Edge

Today's roundup spans a landmark antifungal approval, renewed concern over avian influenza, and fresh clinical evidence on depression treatment, cancer survival, and vaccine durability — with a direct advisory for residents across Cyprus and the eastern Mediterranean.

First-in-Class Antifungal Olorofim Approved for Refractory Aspergillosis

The US Food and Drug Administration has approved olorofim (F2G Ltd), the first member of a new antifungal class — dihydroorotate dehydrogenase (DHODH) inhibitors — for adults with invasive aspergillosis who have failed or cannot tolerate standard therapy. The Phase 3 OREN trial enrolled 214 immunocompromised patients, including recipients of haematopoietic stem cell transplants and those with haematological malignancies, and recorded a 33% clinical response rate against 10% in the best-available-therapy arm. Olorofim works by blocking a fungal enzyme not found in mammalian cells, which underpins its activity against moulds already resistant to azoles and echinocandins — the two pillars of current antifungal care. The European Medicines Agency has granted Accelerated Assessment and a European decision is expected in Q1 2027. Invasive fungal infections cause an estimated 1.5 million deaths annually worldwide; this approval offers a meaningful new option where few existed.

WHO Updates H5N1 Risk Assessment After New Cases in Southeast Asia

The World Health Organization has published a revised interim risk assessment for influenza A(H5N1) clade 2.3.4.4b following five confirmed human infections in Vietnam and Cambodia between late August and 11 September 2026 — all linked to direct contact with infected poultry or backyard birds. No sustained human-to-human transmission has been detected and WHO retains its assessment that the risk to the general public remains low. However, the agency notes an uptick in geographic spread among wild bird populations across Central Asia and the eastern Mediterranean, and urges health authorities to strengthen surveillance, maintain oseltamivir stockpiles, and screen travellers with unexplained influenza-like illness returning from affected regions. The ECDC has updated its Communicable Disease Threat Report accordingly, and Cyprus and other EU member states are advised to review pandemic preparedness protocols.

Psilocybin Shows Durable Six-Month Advantage Over Escitalopram in Depression Trial

A Phase 2b randomised controlled trial published in JAMA Psychiatry has compared a single 25 mg dose of psilocybin with structured psychological support against a standard six-week course of escitalopram 20 mg in 210 adults with moderate-to-severe major depressive disorder. Both arms achieved clinically meaningful response at week 6, but at the 24-week follow-up the psilocybin group showed a remission rate of 48% versus 31% in the escitalopram arm — a difference that reached statistical significance (odds ratio 2.1, 95% CI 1.2–3.7). The trial did not compare the two treatments head-to-head beyond week six; both arms received equivalent psychological support throughout, which researchers acknowledge as a confounding factor. The UK Medicines and Healthcare products Regulatory Agency has granted psilocybin Breakthrough Therapy designation for treatment-resistant depression, and FDA review of a separate Phase 3 application is ongoing. Researchers at Imperial College London caution that the compound remains a controlled substance in most jurisdictions and that self-medication outside a supervised clinical setting carries serious risks.

Final Survival Data Strengthen PARP Inhibitor Case in Prostate Cancer

The PROpel-2 trial, presented at the ESMO Annual Congress and simultaneously published in The Lancet Oncology, reports final overall survival results for olaparib combined with abiraterone acetate and prednisone in men with homologous recombination repair (HRR)-mutated metastatic castration-resistant prostate cancer. Median overall survival reached 42.1 months in the combination arm versus 34.7 months with abiraterone alone (hazard ratio 0.77; 95% CI 0.63–0.94; p=0.008). Benefit was most pronounced in patients carrying BRCA1 or BRCA2 alterations, where median OS extended to 46.3 months against 33.4 months in controls. AstraZeneca has submitted these data to the EMA for a label update. The results are expected to reinforce genetic testing for HRR mutations as a standard step in first-line prostate cancer assessment — a test already reimbursed in Germany, France, and the UK but not yet universally available across Cyprus and Greece.

Real-World European Data Confirm RSV mRNA Vaccine Effectiveness, but Raise Questions for Over-80s

The first full-season European effectiveness analysis of mRESVIA — Moderna's mRNA-based respiratory syncytial virus vaccine approved by the EMA in 2024 — has been published in NEJM Evidence. Drawn from healthcare surveillance networks across eight EU countries during the 2025–2026 Northern Hemisphere season, the study found 72% effectiveness against RSV-associated hospitalisation in adults aged 60–79. Effectiveness fell to 48% among adults aged 80 and older and those with multiple cardiorespiratory comorbidities. The ECDC responded with a technical note recommending that member states review whether annual revaccination is warranted for the oldest and most vulnerable adults. Moderna has noted that a bivalent next-generation formulation is in Phase 2 trials, but no updated vaccine is expected before the 2026–2027 season.

Cyprus and Eastern Mediterranean: September Heat Risk Continues for Elderly and Chronically Ill

The European Centre for Disease Prevention and Control and the Cyprus Ministry of Health have jointly flagged an extended heat-health risk across Cyprus, southern Greece, and coastal Turkey, where daytime temperatures in several locations remained above 37°C through the first week of September 2026. Provisional MoH surveillance data indicate heat-related mortality among adults over 70 was 18% higher than the five-year average for August–September. Clinicians are advised to proactively review medication regimens for patients on diuretics, ACE inhibitors, and NSAIDs, whose fluid-balance and renal-clearance risks are amplified during sustained heat. The Cyprus MoH has re-activated its Heatwave Action Plan, recommending outdoor activity only before 9 am and after 7 pm, free water distribution at community centres, and priority welfare checks for elderly residents living alone. The ECDC alert places Cyprus, Crete, and the Dodecanese islands in the highest-risk tier through at least 18 September.

This article is provided for journalistic and informational purposes and does not constitute medical advice. Readers should consult a qualified healthcare professional before making any changes to their treatment or health management.