Dive Brief:
- AstraZeneca's Lokelma has just picked up an approval from the Food and Drug Administration for the treatment of adults with high levels of blood potassium, known as hyperkalemia.
- The approval, announced Friday, is based on three double-blind, placebo controlled trials and an open-label trial. In the studies, patients reached normal blood potassium levels within 2.2 hours and 98% had normal levels within 48 hours.
- Lokelma picked up an EU approval for the drug in March 2018.
Dive Insight:
People who have chronic kidney disease or who take drugs to treat heart failure can end up with increased levels of potassium in the blood, which can cause muscle pain and weakness and also increase their risk of cardiac arrest and death. Around a third of people with severe hyperkalemia may die if they are not treated rapidly.
"We are pleased by today’s FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalemia. Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors," said Sean Bohen, EVP of global medicines development and chief medical officer at AstraZeneca.
Lokelma (sodium zirconium cyclosilicate)'s path towards approval in the U.S. has been frustrating for the British pharma. Also known as ZS-9, Lokelma received a complete response letter (CRL) in May 2016, when the FDA found issues in a pre-approval manufacturing inspection. This happened again in March 2017. AstraZeneca picked up Lokelma is a $2.7 billion deal from its originator, ZS Pharma.
Other than modifying existing medications, which can affect patients' outcomes, there are few options for ongoing management of hyperkalemia. Relypsa's Veltassa (patiromer) is on the market, and initially carried a black box warning because of interactions with other drugs. This could have been a differentiator for Lokelma had it received an earlier approval, but the warning has now been removed for Veltassa and the drug simply has to be taken three hours apart from other oral medications. Relypsa is now part of Swiss pharma Galenica Group.