Tag Archives: Ankylosing spondylitis

NICE Publish Guidance on Golimumab

NICE Publish Guidance on Golimumab

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Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if:
it is used as described for adalimumab and etanercept in ‘Adalimumab, etanercept and infliximab for ankylosing spondylitis’ (NICE technology appraisal guidance 143) and
the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme.

People currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept described in NICE technology appraisal guidance 143 should have the option to continue golimumab until they and their clinician consider it appropriate to stop.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my 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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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

NICE Publish Guidance on Golimumab in Ankylosing Spondylitis

NICE Publish Guidance on Golimumab in Ankylosing Spondylitis

Full Text HEre

Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if:
it is used as described for adalimumab and etanercept in ‘Adalimumab, etanercept and infliximab for ankylosing spondylitis’ (NICE technology appraisal guidance 143) and
the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme.

People currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept described in NICE technology appraisal guidance 143 should have the option to continue golimumab until they and their clinician consider it appropriate to stop.



For Assistance with Submitting Evidence to NICE Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my 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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

Fill Out the Short Form Below…


  1. (required)


  2. (valid email required)

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

EMEA Guidlines on Clinical Investigation of Medicinal Products for The Treatment of Ankylosing Spondylitis.

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:

  1. improvement of symptoms and signs such as pain and stiffness or enthesopathy
  2. improvement of physical function
  3. slowing or prevention of structural damage
  4. 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.

ida consultants freestrategyconsultation 515x64 EMEA Guidlines on Clinical Investigation of Medicinal Products for The Treatment of Ankylosing Spondylitis.

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