AstraZeneca, a biopharmaceutical company, has recently stopped its ongoing clinical trial on Lokelma. Lokelma is a potassium-reduction drug that has been approved for treating hyperkalemia.
AstraZeneca decided to discontinue the clinical trial because the timeline of enrolment is increasing and the event rates are very low in Phase 3 clinical trials for STABILIZE-CKD and DIALIZE, respectively.
Lokelma has been approved because it treats hyperkalaemia patients in a broader range. Lokelma has been approved in 56 countries, including the United States, China, and the European Union.
According to an article from Frontiers, hyperkalaemia is a complication that occurs in patients with heart failure and chronic kidney disease.
According to a clinical case report on hyperkalaemia, patients with hyperkalaemia have serum potassium levels of more than 5.0 mEq/L and show symptoms of weakness and decreased tendon reflexes.
An article from Springer mentions that the generic name of Lokelma is sodium zirconium silicate, which is a non-absorbable and non-polymer zirconium silicate compound. This drug acts by reducing the potassium levels in the gastrointestinal tract and increasing the excretion of potassium in the feces, thereby lowering the potassium levels in the blood. 5 to 10 g of a once-daily dose of this drug is enough to maintain normal serum potassium levels in the blood.
In clinical trials, this drug has also not been shown to affect the calcium and magnesium levels in the blood.
According to AstraZeneca, Lokelma is a potassium-reducing agent that is odorless and tasteless. Its recommended initial dose is 10g. In clinical trials, patients receiving Lokelma achieved normal blood potassium levels in 2.2 hours.
The original developer of the drug Lokelma was ZS Pharma, but AstraZeneca bought the company for 2.7 billion dollars in 2015.
Lokelma previously had a code name called ZS-9. It is estimated that Lokelma will generate 799 billion dollars in 2029, according to GlobalData. In 2022, this drug was sold for 289 million dollars. In 2023, for the first nine months, this drug was sold for 300 million dollars.
What do you think about stopping an effective drug like Lokelma, a serum potassium-reducing agent, to manage hyperkalemia patients in clinical trials?
References:
1) https://link.springer.com/article/10.1007/s40265-018-0991-6
2) https://www.astrazeneca.com/media-centre/press-releases/2018/lokelma-approved-in-the-eu-for-the-treatment-of-adults-with-hyperkalaemia-22032018.html
3) https://www.frontiersin.org/articles/10.3389/fmed.2023.1137981/full
4) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7495804/
(Inputs from various media sources)
(Rehash/Rohini Devi)
