The European Union's Committee for Propriety Medicinal Products (CPMP) has confirmed the efficacy of calcitonin containing products in the treatment of osteoporosis, following an Article 31 referral.

The Opinion from the CPMP concerns Miacalcic (salmon calcitonin) from Novartis Pharma AG, which is widely used around the world for the treatment of post-menopausal osteoporosis and other bone disorders.

The Opinion will harmonize prescribing advice across the European Union. Article 31 Referrals are used to review medicines marketed in the European Union in the light of new data or information related to quality, safety and efficacy.

In formally adopting the Opinion, the CPMP states that:

Intranasal calcitonin - is approved for the treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures
Injectable calcitonin - is approved in the prevention of acute bone loss due to sudden immobilization such as in-patients with recent osteoporotic fractures. It is also approved for Pagets disease and hypercalcaemia of malignancy

The CPMP also states that in the intranasal formulation, a reduction in hip fractures has not been demonstrated and this will be highlighted within the new prescribing information.

"Not only has Miacalcic been shown in studies to increase bone mass and prevent new spinal fractures in post-menopausal osteoporosis, its effectiveness has now been confirmed in a rigorous review by the European regulatory authorities. This extensive analysis by the CPMP provides patients, carers and treating physicians with comprehensive reassurance about the effectiveness of Miacalcic and other calcitonin treatments," said Dr Mathias Hukkelhoven, Novartis global head of regulatory affairs.

Professor John Kanis from the WHO Collaborating Center for Metabolic Bone Diseases, University of Sheffield, United Kingdom, confirmed the importance of the Opinion. He said: "For physicians treating patients with established osteoporosis, it is essential that a broad range of treatment options are available. Different treatments are appropriate for different patients and calcitonin products are valuable because they are effective, easy to use and show a very good safety profile."

Professor Pierre Delmas speaking on behalf of the International Osteoporosis Foundation (IOF) said: "This is excellent news for patients. The number of people with osteoporosis is expected to double over the next 50 years and this represents one of the major health problems of today. In the future it may become even more important with the aging European population. Although prevention of osteoporosis and lifestyle advice - physical mobility, diet, and especially high intake of calcium - is important, patients who are at high risk of, or suffer from osteoporotic fractures need effective treatment to reduce the risk of fractures. A variety of drugs inhibiting bone resorption are currently available."

Osteoporosis is an increasingly common condition characterized by a reduced amount of bone mass and disruption of bone structure, leading to reduced bone strength and increased risk of fracture. It is the most common bone disease that affects humans. Osteoporosis is often referred to as the 'silent epidemic' as it progresses without any obvious signs, sometimes for decades, until the person affected suffers a bone fracture. These fractures are usually in the spine, wrist, hip or upper arm. Bone pain - which can be very debilitating - is the commonest symptom in people with osteoporosis. Osteoporosis increases with age, affecting an estimated one-third of women aged 60 to 70 and two-thirds of women aged 80 or older.

Calcitonin has been used for thirty years in the treatment of osteoporosis and other bone disorders. Calcitonin is a natural polypeptide hormone that causes rapid and reversible inhibition of bone resorption. Calcitonin can be given by injections or by a nasal spray, which is easier for patients to use and is associated with fewer side-effects5.

Miacalcic is registered in 97 countries around the world and it is estimated that it has been administered for over 3 million patient years since it was first launched in 1974 in an injectable form. Miacalcic Nasal Spray received its first approval in 1987. Its first European Union marketing license for post-menopausal osteoporosis was obtained in Portugal in 1987, followed by subsequent approvals in other countries.

With the arrival of new clinical data with Miacalcic Nasal 200IU, a Mutual Recognition Procedure (MRP) was initiated in 1999 with the Republic of Ireland as the Reference Member State. As an outcome of the MRP, seven member states - Austria, Belgium, Finland, Germany, Italy, Luxembourg and the UK - granted approval for the treatment of post-menopausal osteoporosis in July 2000. Novartis withdrew the MRP application in France, Sweden and The Netherlands.