AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers
Executive Summary
EU, US and Japanese regulatory agencies will provide advice to developers of antibiotics that is consistent with the agreements they have reached on aligning their data requirements.
Drug regulators in the EU, US and Japan have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in a bid to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
The move is designed to respond to increasing global concerns over antimicrobial resistance (AMR) and the lack of development of new antibiotics.
The European Medicines Agency, the Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency have agreed that certain requirements for clinical studies for specific types of infections such as urinary and intra-abdominal infections could be harmonized, the EMA announced on June 12. Areas identified for convergence include criteria for patient selection and response in urinary tract and intra-abdominal infection trials.
Agreement was also reached on certain aspects of clinical development programs for drugs intended to treat patients infected with multi-drug resistant bacteria.
The EMA, PMDA, and FDA said in a joint statement that they would update their guidance documents to reflect the agreed areas of convergence. In the meantime, they plan to provide advice to drug developers that is consistent with the agreements reached. “Prior advice on drug development is not impacted,” they noted.
Still Working On Differences
The agreement follows two meetings where the three agencies discussed regulatory approaches for evaluating new antibacterial agents: the first meeting took place in September last year and the second in April this year.
“A number of areas of similarity were identified with regard to clinical trial design recommendations” – EMA, FDA, PMDA
During the second meeting, the agencies discussed in detail clinical trial recommendations for respiratory tract, urinary tract, intra-abdominal, and skin infections, as well as for drugs intended to treat patients with multi-drug resistant infections.
“A number of areas of similarity were identified with regard to clinical trial design recommendations, such as patient selection criteria, and endpoints for certain types of infections,” they said.
Areas were also identified where differences still remain, for example, regarding which endpoints should be regarded as primary in community-acquired bacterial pneumonia and skin infection trials. “Further scientific discussion and sharing of information may help to achieve convergence in those areas,” the agencies said.
They agencies said they would continue to work together on areas where differences remain so as to minimize the impact on clinical development programs. A third tripartite meeting has been proposed for October.
Making Use Of PRIME
Last month, the EMA encouraged developers of AMR therapies to consider applying for designation under the agency’s priority medicines (PRIME) scheme for getting medicines for unmet medical needs to patients faster. While there have been around 100 applications for PRIME since the scheme was launched in March 2017, none of them has been for an investigational product for AMR. The EMA said the unmet medical need in this area was undeniable.
From the editors of Scrip Regulatory Affairs.