WHO’s 2025 Essential Medicines Lists (EML), published Friday, has included the active ingredients in popular weight loss drugs like Ozempic and Wegovy –  semaglutide or other comparable  GLP-1 receptor agonists – in a recommendation that recognizes the growing importance of the drugs in clinical treatment of diabetes worldwide. 

These drugs, as well as new PD-1/PD-L1 cancer therapies, notably pembrolizumab and two other therapeutic alternatives, were also among the 20 new medicines added to the 2025 WHO EML. 

The EML also includes rapid acting insulin analogues to the list for the first time.  Longer-acting synthetic insulin formulas were first included in the list in 2021, as an alternative to human-derived insulin products.

Another 15 drugs were added to a separate Essential Medicines List for children (EMLc) in this year’s listing, which is published every two years. The new list includes new drugs for cystic fibrosis and haemophilia, as well as recently approved vaccines for malaria and mpox. Also on Friday, WHO removed its declaration of an mpox Public Health Emergency of International Concern (PHEIC), noting that cases in Africa, which had been most affected by the recent emergency, had stabilized.  

The EML lists are used by over 150 countries, as well as insurance and health care providers, to guide decisions about procurement and provision of critical medicines for virtually every infectious and non-communicable disease condition. 

The 24th edition of the EML includes  about critical medicines for 563 drugs, on the adult list, and 361 treatments on the children’s listing.  

Short-acting insulin completes the package

This latest insulin addition rounds out the package of recommended insulin treatments, said WHO’s Deus Mubangizi.

“These are complementary; there those conditions where it’s more appropriate to use long-acting but also we need have conditions where we need short acting,” he said at a Friday press briefing.   

The inclusion of pembrolizumab and its counterparts follows on evidence demonstrating that the drugs, used in treatment of metastatic cervical, colorectal and lung cancer, prolong survival by at least four to six months, added WHO’s Lorenzo Moja, also at the briefing.

In comparison, trials in some of the newer, and also pricier, breast cancer drugs submitted for inclusion in the list, “are still maturing so the follow up of these patients is not yet consolidated,” Moja said, adding:  “The expert committee had a preference for those results in which we had long term follow up data and we are sure about the effect on overall survival and quality of life.” 

Inclusion of new insulin analogues and GLP-1 agonist drugs welcomed by access advocates

Elizabeth Jarman, of Médecins Sans Frontières ACCESS initiative welcomed the WHO’s inclusion of the insulin analogues and GLP-1 agonists as a “critical milestone” – but called upon countries to make the treatments more affordable as well. 

“We welcome the inclusion of rapid-acting insulin analogues and GLP-1 agonists to the World Health Organization’s (WHO) Model List of Essential Medicines (EML) as a critical milestone on the path towards increasing access to diabetes treatment,” said Jarman.  

“In our experience of providing diabetes care in low-resource settings and humanitarian emergencies, rapid-acting insulins and GLP-1s are unaffordable and often unavailable. Current prices are unacceptably high, with rapid-acting insulin analogues priced as much as 75 times and GLP-1 agonists 400 times higher than what they can be profitably produced for, according to a recent MSF study. 

“We call on countries to take urgent steps to update their national EMLs, begin procurement planning, and – alongside the WHO – demand pharmaceutical corporations make these key diabetes treatments available in-country by immediately registering them and – critically – making them affordable.” ​ 

While gaining greater fame for obesity control, WHO has in fact recommended GLP-1 agonists as glucose-lowering therapy for adults with type 2 diabetes mellitus  “with established cardiovascular disease or chronic kidney disease, as well as obesity, defined as body mass index (BMI) ≥ 30kg/m2,” according to the EML.

The EML did not explicitly recommend the drugs for weight loss per se, but it contains guidance on “who can most benefit from the new drugs”, WHO said. 

GLP-1 agonists work by mimicking the body’s natural GLP-1 hormone to regulate blood sugar. They stimulate the pancreas to release insulin, reduce the liver’s sugar production, and slow down digestion. The medications also act on the brain to suppress appetite and have been shown to yield other benefits for heart and kidney health.

Exclusion of drug for spinal muscular atrophy decried

However, another medicines access group, Knowledge Ecology International (KEI) decried the exclusion, for the second time, of risdiplam, a drug that can significantly reduce the symptoms of spinal muscular atrophy, a rare genetic condition.

“The second rejection of risdiplam is appalling,” said director Jamie Love, of the drug, which is currently produced by the Swiss-based Roche.

“This is exactly the type of drug for a rare disease the EML should embrace. It works and it’s easy and cheap to make and distribute generic versions. The consequences of no access are terrible for many children.”

The proposal for including the drug was apparently discarded by the EML expert group, Love said, because results of an ongoing trial on pre-symptomatic infants,  had not yet been published in a peer-reviewed journal at the time the group made its decisions. Preliminary results showed a very high rate of infants reaching key milestones for sitting, walking and other motorskills after 12 months of treatment.

New cystic fibrosis drug addition hailed as a breakthrough 

Meanwhile, a leading cystic fibrosis patient advocate group hailed the inclusion of the new drug ivacaftor and its therapeutic alternatives, as a “historic breakthrough in the fight for global access to lifesaving cystic fibrosis treatment.”

The elexacaftor/tezacaftor/ivacaftor (ETI) trio –  better known as Trikafta/Kaftrio, was included in the EML for both adults and children.  

“This decision is a turning point. For the first time, a medicine specifically aimed at treating CF has been included on the EML and the world’s leading health authority has recognised that Trikafta is not a luxury drug, but an essential medicine – and that every child and adult living with CF should have the right to access it,” stated the group Right to Breathe.

“This is a powerful statement from the WHO: not only is Trikafta recognised as essential, but its inclusion is about breaking down barriers to access and ensuring patients everywhere – not just in the richest countries – can benefit from its lifesaving impact.” 

David Reddy, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, hailed the addition of multiple new, cutting-edge treatments on the updated EML, saying their inclusion,”highlights how scientific advances are transforming how we prevent, treat and cure disease, and reinforces the importance of ensuring patients everywhere can benefit from them.”

While the EML expert group that vets new drugs has also held back, at times, on recommending cutting edge treatments specifically because of their high costs, “tiered pricing, voluntary licensing and value-based healthcare models” can help expand access, Reddy stressed.

Healthcare system strengthening is also a critical, and often overlooked, part of the equation, he added, noting “healthcare systems need to be strengthened with the right infrastructure, diagnostics and trained professionals in place, alongside effective regulatory pathways and sustainable procurement, to help ensure these innovations can achieve greatest impact for patients. “

Image Credits: Chemist4u.