1. Pink Sheet
  2. >>Geography
  3. >>International

Monkeypox: WHO Advises Antiviral Use In Trials Or Expanded Access Programs

 
• By Ian Schofield

With more than 1,200 confirmed cases of monkeypox in 28 non-endemic countries and disease incidence also rising in Africa, the WHO and the US CDC have each updated their guidance on the use of antiviral products. The US has just ordered 500,000 more doses of Bavarian Nordic's smallpox vaccine, Jynneos.

Tecovirimat and Brincidofovir, antiviral drugs 3d rendering medical illustration. Both are studied for use on monkeypox virus infections, indicated for smallpox.
Tecovirimat and brincidofovir may be used for severe monkeypox • Source: Shutterstock

Antivirals such as SIGA Technologies, Inc's tecovirimat, Chimerix, Inc.'s brincidofovir (Tembexa) and generic cidofovir can be used in cases of severe monkeypox disease, preferably in the context of randomized clinical trials with the collection of standardized clinical and outcomes data to quickly generate safety and efficacy data, the World Health Organization advises in its latest guidance.

If clinical trials are not possible, antivirals may be used under expanded access protocols such as MEURI (monitored emergency use...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from International

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

More from Geography

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.