Regulatory Focus™ > News Articles > Revisions to Osteoporosis Guideline Called for by EMA

Revisions to Osteoporosis Guideline Called for by EMA

Posted 01 November 2012 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease.

The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Glucocorticoids are used to treat a broad spectrum of conditions, including allergies, asthma and autoimmune diseases.

The lack of guidance is problematic because approximately 1% of the population and 2.5% of the elderly are prescribed glucocorticoids, which can cause a condition known as glucocorticoid-induced osteoporosis (GIOP).

To better address the needs of patients, EMA said it is proposing to update the existing guideline, CPMP/EWP/552/95 Rev. 2, to include revisions on the design of clinical trials and the use of endpoints. Also proposed are specific demonstrations of efficacy for various subpopulations, including children and pre-menopausal women.

Once adopted by EMA's Committee for Medicinal Products for Human Use (CHMP), regulators said they expect a draft version of the new guideline to be released within six months and a final version within 15 months. EMA said it hopes the new guideline will increase the number of products used to treat GIOP by improving the quality and comparability of studies conducted and submitted by industry.

The call for guidance is the second time osteoporosis medications have been targeted by EMA regulators in recent months. In July 2012, EMA announced the long-term risk of calcitonin-containing medicines was increasingly associated with a risk of cancer, and recommended that any treatment involving the medications be on a short-term basis.  "Taking into account the limited efficacy of calcitonin when used to treat post-menopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in this indication," EMA wrote at the time.

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