Doc. Ref.: EMEA/426906/2009 EMEA/H/C/570

Mimpara

cinacalcet

EPAR summary for the public

What is Mimpara?

Mimpara is a medicine that contains the active substance cinacalcet. It is available as light green, oval tablets (30, 60 and 90 mg).

What is Mimpara used for?

Mimpara is used in adults and elderly patients in the following ways:

•    to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition. Mimpara can be used as part of treatment including phosphate binders or vitamin D sterols;

•    to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate. ‘Primary’ means that the hyperparathyroidism is not caused by any other condition.

The medicine can only be obtained with a prescription.

How is Mimpara used?

In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day. The dose is adjusted every two to four weeks, according to the patient’s PTH levels, up to a maximum of 180 mg once a day. PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara. Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Mimpara. Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.

In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day. The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.

Mimpara is taken with food or shortly after a meal.

7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu

© European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged.

How does Mimpara work?

The active substance in Mimpara, cinacalcet, is a calcimimetic agent. This means that it mimics the action of calcium in the body. Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.

How has Mimpara been studied?

Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 dialysis patients with serious kidney disease. The studies lasted for six months. The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.

Mimpara has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective. The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study). The study continued for over three years. A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year. Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.

What benefit has Mimpara shown during the studies?

In dialysis patients with serious kidney disease, about 40% of the patients taking Mimpara had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo. Mimpara brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.

Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17). The results of the additional studies supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.

What is the risk associated with Mimpara?

The most common side effects with Mimpara in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting. In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting. For the full list of all side effects reported with Mimpara, see the Package Leaflet.

Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.

Why has Mimpara been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Mimpara’s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The Committee recommended that Mimpara be given marketing authorisation.

Other information about Mimpara:

The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara to Amgen Europe B.V. on 22 October 2004. The marketing authorisation was renewed on 22 October 2009.

The full EPAR for Mimpara is available here.

This summary was last updated in 10-2009.

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