European Medicines Agency Recommends Granting Marketing Authorisation for Cinacalcet Mylan

It is intended for reduction of hypercalcaemia in patients with parathyroid carcinoma

On 24 September 2015, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product cinacalcet (Cinacalcet Mylan), intended for the treatment of secondary hyperparathyroidism and reduction of hypercalcaemia in patients with parathyroid carcinoma.

The applicant for this medicinal product is MYLAN S.A.S.

Cinacalcet Mylan will be available as 30 mg, 60 mg and 90 mg film-coated tablets. The active substance of Cinacalcet Mylan is cinacalcet, a calcimimetic agent (ATC code: H05BX01). It increases the sensitivity of the calcium-sensing receptors on the parathyroid glands and other tissues, leading to reduced secretion of parathyroid hormone by the parathyroid glands and a resultant decrease in blood calcium levels.

Cinacalcet Mylan is a generic of Mimpara, which has been authorised in the EU since 22 October 2004. Studies have demonstrated the satisfactory quality of Cinacalcet Mylan, and its bioequivalence to the reference product Mimpara.

The full indication is:

"Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.

Reduction of hypercalcaemia in patients with:

  • parathyroid carcinoma.
  • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated."

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.