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The EU has approved a new antibiotic for serious illnesses such as pneumonia and urinary tract infections, marking a step forward in the drive to combat the growing resistance of “superbugs” to existing drugs.
Emblaveo, marketed in Europe by US pharmaceutical company Pfizer, combines two existing medicines to tackle so-called Gram-negative bacteria that are among the leading drug-resistance threats.
The European Commission is the first authority to approve the treatment, which is likely to be used in a relatively narrow group of serious cases to reduce the risk it will trigger a surge in anti-microbial resistance (AMR).
Health policymakers are trying to provide an incentive to pharma businesses to invest more in dealing with the scourge of pathogen resistance. AMR is already estimated to be linked to 5mn deaths a year worldwide.
“Emblaveo really is going to make a difference. It’s a drug that’s active against [resistant] pathogens that gives us a tool to treat the type of infection that we don’t have good options for now,” said Jay Purdy, Pfizer’s vice-president of global medical affairs, before the announcement.
Infections from multi-drug resistant bacteria cause an estimated 35,000 deaths in the EU every year, according to the European Medicines Agency. The World Health Organization has identified antimicrobial resistance as one of the top 10 global public health threats. By 2030, the global cost in lost gross domestic product could amount to $1tn-$3.4tn a year, according to World Bank estimates.
Emblaveo is the second antibiotic the EU has approved this year, after Exblifep, another treatment for complicated urinary tract infections caused by Gram-negative bacteria which is produced by Germany-based Allecra Therapeutics, was approved last month. It approved four antibiotics in 2020.
The drug will be marketed for use against bacteria that produce enzymes known as Metallo β-lactamases (MBL). Some of these bacteria are listed among the most critical priority pathogens by the WHO. The MBL enzymes break the structure of many existing antibiotics, destroying their efficacy.
People who will receive treatment with Emblaveo will include very frail patients, those with severe infections or with few other treatment options, and those in regions where drug-resistant bacteria are more prevalent, Purdy said.
Emblaveo is a “really interesting combination” to combat drug resistance but there is “scope for improvement” in its antibacterial action, said Chris Schofield, an Oxford university professor and head of chemistry at the Ineos Oxford Institute for antimicrobial research.
He added that Emblaveo’s pricing “will be a key question since some of the resistant bacteria it targets are most prevalent in low- and middle-income countries”.
Developing new antibiotics is often unattractive for pharmaceutical companies, as research and development costs are high but their use is designed to be limited to reduce the risk of the product driving a surge in bacterial resistance.
Emblaveo was developed in partnership with US pharma company AbbVie and with financial support from US and EU public bodies. Purdy said Emblaveo’s use was unlikely to be widespread, reflecting the weak financial incentive for developing antimicrobials.
“You should really save it for those patients that need it, otherwise you build resistance,” he said. “[This means] the return on investment for antibacterials is much lower than other types of drug development.”
Andrea Chiarello, Pfizer’s head of EU government affairs, said drugmakers needed more encouragement to discover new antimicrobials and develop drugs.
As part of pharmaceutical legislation reforms, the commission has proposed incentivising antibiotics by granting companies that develop priority antimicrobials longer exclusivity periods on regulatory data. Such “transferable exclusivity vouchers” could be applied to other drugs in their portfolios.
But Chiarello said the package “was not attractive enough” owing to the limited number of drugs to which it applied. As Emblaveo is a combination of two existing antibiotic treatments, aztreonam and avibactam, it would not qualify as a “priority” drug eligible for a voucher.
