Regulatory Focus™ > News Articles > WHO Calls for New Antivenom Treatments as Supplies Dwindle

WHO Calls for New Antivenom Treatments as Supplies Dwindle

Posted 04 December 2015 | By Zachary Brennan 

WHO Calls for New Antivenom Treatments as Supplies Dwindle

The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective anti-venom treatment are due to run out in 2016. Companies can now apply, with no submission fees, to have new treatments assessed by WHO beginning in March.

About five million people are bitten by snakes every year, causing upward of 125,000 deaths and leaving 400,000 people permanently disabled or disfigured, according to the WHO, which also notes that sub-Saharan Africa will be disproportionately affected by the supply shortage, as about 30,000 people from the region die from snake bite each year.

“Antivenoms with a favourable risk‒benefit ratio will be entered into a list on the WHO website, where it can be accessed readily by procurement agencies and other relevant parties,” the organization said.

WHO also said that it may develop a prequalification process for antivenoms if the experience gained in carrying out these initial risk-benefit assessments confirms that “this would generate significant public health benefit.”


Doctors without Borders (MSF) has spear-headed the campaign to raise awareness about the neglected antivenom market as supplies of one of the few products - Sanofi’s Fav-Afrique - that can treat multiple snake bites across Africa runs out.

In 2010, Sanofi said it stopped production of Fav-Afrique because products in competition with it, whose production costs Sanofi “cannot match,” have expanded in Africa and “progressively replaced” Fav-Afrique as demand for Sanofi’s treatment decreased “six fold."

A Sanofi spokeswoman told Focus: "Sanofi Pasteur has decided to reallocate the production facility to other life-saving public health priorities such as equine origin rabies immunoglobulins. Options for transferring experience and technology to other immunoglobulin producers are being identified so as not to lose the equine-origin anti-venom immunoglobulins manufacturing know how that Sanofi Pasteur has built since the company started manufacturing anti-venom products more than 30 years ago."

But Sanofi waited to reveal its decision to stop production until July 2013, according to MSF, which effectively means that there will be a gap for when product is available. MSF noted that the expiry date for the last batch of Fav-Afrique produced is June 2016 and that many of the other products on the market have limited or no clinical data.

“While Sanofi decided to transfer the technology on how to produce Fav-Afrique to another company (called a tech transfer), the contracts for tech transfer are not expected to be finalised until the end of 2016 – six months after the last batch produced expires,” MSF said. “And this means that the first batch of a replacement Fav-Afrique anti-venom is not expected to be produced until the end of 2018 or early 2019 – two and a half to three years after the last Sanofi batch expires.”

Africa is expected to be hit the worst by the shortage. MSF estimates that in its Paoua project in northern Central African Republic, which receives 300–400 bites per year, the use of Fav-Afrique has shown mortality rates to be under 0.5%, or less than one in 200 people. Mortality could rise to one in 10 people without the drug, the group warns.

WHO Submissions

Company submissions for new treatments received before the end of February 2016 will be included in the first round of joint expert assessments planned for March 2016, WHO says.

To facilitate assessment planning, manufacturers are asked to indicate their interest in submitting an application by email to:

WHO response to need for quality assured anti-venoms

Sanofi Comment on Fav-Afrique Supply

Doctors Without Borders

A market failure case study: African snake antivenoms

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.