Study highlights limited access, financial challenges for new antibiotics
Patients in several high-income countries still have limited access to most of the new antibacterials approved since 2010, and as a result sales revenue for these drugs has been insufficient—findings that highlight the poor commercial prospects for new antibiotics, researchers reported yesterday in Clinical Infectious Diseases.
To better understand barriers to effective antibacterial therapy in high-income countries, the researchers examined patient access to new antibacterials in G7 countries (Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States) and seven other high-income countries in Europe, looking at the commercial launch dates, the lag time between regulatory approval and commercial launch, and sales data. They included all new molecular entity antibiotics approved by either the US Food and Drug Administration, the European Medicines Agency (EMA), Health Canada, or the Japanese Pharmaceuticals and Medical Devices Agency from Jan 1, 2010, through Dec 31, 2019.
Of the 18 antibacterials identified (16 antibiotics and 2 products for Clostridioides difficile), the majority were accessible in only three countries (the United States, United Kingdom, and Sweden), and the remaining countries had access to less than half of them. Only 4 antibacterials were launched in the European countries studied, and only 2 were launched in all 14 countries. European marketing authorization did not lead to automatic European access, as only a few of the 14 antibacterials approved by the EMA were commercially launched. No significant difference in access between innovative and non-innovative products was observed.
Median annual sales in the first approval market (generally the United States) for all 18 drugs were $16.2 million. Sponsors of four of the antibacterials filed for bankruptcy following regulatory approval, and sponsors for three other drugs had market capitalizations less than $300 million.
“Mean sales of $16.2 million are insufficient to cover ongoing commercialization costs, including manufacturing, regulatory, medical affairs, and post-approval commitments, with no opportunity to recover sunk R&D [research and development] costs,” the study authors wrote. “This economic situation explains why sponsors for seven of the eighteen products suffered either bankruptcy or market capitalizations below the sunk cost of R&D, with the bulk of this economic damage coming since April 2019.”
The authors say the findings reinforce calls for new economic incentives that will delink profits for new antibiotics from unit sales.
Jul 12 Clin Infect Dis abstract
Point-prevalence study reveals high antibiotic use in Ghanaian hospitals
Point-prevalence surveys conducted in antimicrobial resistance (AMR) surveillance sentinel hospitals in Ghana found high levels of antibiotic use and empiric prescribing, researchers reported yesterday in JAC-Antimicrobial Resistance.
Overall prevalence of antibiotic use across the sentinel sites from September through December 2019 was 54.9% (1,591 out of 2,897 patients), ranging from 48.7% to 67.2%. The highest prevalence of antibiotic use was observed in adult intensive care units (89.3%). The average number of antibiotics per patient was 1.7, with 66% administered via the parenteral route, and 53.9% of patients received at least one antibiotic on the day of the survey.
Most antibiotics (52.2%) were used to treat infections, while 26.1% were for surgical prophylaxis and 13.7% had no documented indication. Of the 1,367 antibiotic prescriptions for treatment of infections, approximately 96% were prescribed empirically. Only 48.2% of the antibiotic prescriptions had a documented reason in the notes.
There were 35 different antibiotics prescribed across all hospitals. The five most commonly used antibiotics were metronidazole (20.6%), cefuroxime (12.9%), ceftriaxone (11.8%), amoxicillin/clavulanic acid (8.8%), and ciprofloxacin (7.8%).
“Such high antibiotic prescription rates in hospitals are fuelled by factors such as inadequate diagnostic microbiology services and differences in the organizational structures of hospitals,” the study authors wrote. “Given the association between antimicrobial use and the selection of resistant pathogens, the high frequency of antimicrobial use in Ghana is a reflection of the AMR problem in the country.”
The authors say the findings could be used as benchmarks for improving antibiotic prescribing.
Jul 12 JAC-Antimicrob Resist study