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

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

More from International

Global Pharma Guidance Tracker - May 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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

 

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

 

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 

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.

More from Geography