The EMEA has published guidance on the clinical evaluation of new medical products the treatment and ankylosing spondylitis (AS), a chronic inflammatory disease that affects primarily sacroiliac joints and the axial skeleton. The prevalence has been estimated at between 0.1 and 1.1% of the population.
The guidance describes the patient characteristics/selection criteria that should be considered for inclusion of patients into clinical trials. This is of particular importance in order to establish the correct diagnosis, distinguish patients with AS from those suffering from other subtypes of spondyloarthritis, and appropriately assess the severity and extent of the disease at baseline.
The different domains to assess efficacy and medicinal product are described as well is the therapeutic claims that are distinguished from the regulatory perspective:
- improvement of symptoms and signs such as pain and stiffness or enthesopathy
- improvement of physical function
- slowing or prevention of structural damage
- prevention of disability
The guidance, furthermore, outlines strategies for early studies in man (does response trials) as well as therapeutic complimentary trials including acceptable primary and secondary endpoints to assess efficacy. Specific aspects of evaluation of clinical safety are also highlighted, specifically a need for long-term safety data in the treatment of this chronic disease.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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