Lokelma

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On 25 January 2018 the Committee for Medicinal Products for Human Use (CHMP) confirmed its previous positive opinion and recommended the granting of a marketing authorisation for the medicinal product Lokelma. This follows an inspection of the manufacturing site for Lokelma’s active substance confirming that the site is compliant with good manufacturing practice.

Lokelma is intended for the treatment of hyperkalaemia. The applicant for this medicinal product is AstraZeneca AB.

Lokelma will be available as 5-g and 10-g powder for oral suspension. The active substance of Lokelma is sodium zirconium cyclosilicate (ATC code: V03AE10). Sodium zirconium cyclosilicate selectively binds potassium in exchange for hydrogen and sodium cations throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen. This lowers serum potassium levels by drawing potassium into the GI tract and increasing faecal potassium excretion to resolve hyperkalaemia.

The benefits with Lokelma are its ability to lower serum potassium levels. The most common side effects are hypokalaemia and oedema related events.

The full indication is: "treatment of hyperkalaemia in adult patients".

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

Name Language First published Last updated
CHMP summary of positive opinion for Lokelma (English only) 2017-02-24 2018-01-26

Key facts

Product details for Lokelma
NameLokelma
INN or common name

sodium zirconium cyclosilicate

Therapeutic area Hyperkalemia
Active substance

sodium zirconium cyclosilicate

Date opinion adopted23/02/2017
Company name

AstraZeneca AB

StatusPositive
Application typeInitial authorisation