Please login to the form below

Not currently logged in
Email:
Password:

AZ nears EU approval for hyperkalaemia drug Lokelma

CHMP adopts positive opinion for the potassium-binding treatment
AZ

AstraZeneca's hyperkalaemia therapy Lokelma has picked up a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), bringing it one step closer to European licensing.

It has been recommended for use in adult patients with hyperkalaemia, and would be made available as a 5g or 10g orally-administered treatment.

Backing from the CHMP came on the back of clinical trials of over 1,600 patients, which showed significantly reduced or normal levels of blood serum potassium within 48 hours, lasting up to 28 days.

Lokelma (sodium zirconium cyclosilicate) is a potassium-binding compound designed to reduce excessive levels of serum potassium by drawing it into the gastrointestinal tract.

The drug was originally developed by ZS Pharma, which described Lokelma as a “potential best-in-class treatment” and tipped it as a potential blockbuster.

AstraZeneca acquired the pharma firm in a $7.2bn deal at the end of 2015 to get access to the drug, however faced a shock setback last May when it was rejected by the FDA due to manufacturing issues.

Not required to provide new clinical trial data, it was resubmitted for US approval in October last year and the company expects a decision from the FDA in the first half of this year.

Hyperkalaemia is commonly associated with chronic heart failure and chronic kidney disease, and carries risk of potentially fatal cardiac arrhythmias.

Speaking at the time of ZS Pharma's acquisition, AstraZeneca's chief executive Pascal Soriot said the risk of hyperkalaemia “is underappreciated and prevalence is increasing”.

Article by
Rebecca Clifford

27th February 2017

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Porterhouse Medical Group

The Porterhouse Medical Group provides market research, insights, and scientific and medical communication services to the pharmaceutical industry across the...

Latest intelligence

Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...

Infographics