AstraZeneca’s drug Lokelma approved in China
pharmafile | January 6, 2020 | News story | Sales and Marketing | AstraZeneca, China, FDA, eu commission, kidney failure, potassium
AstraZeneca’s Lokelma has been approved by the National Medical Products Administration in China.
This is due to positive results based on its clinical trials as well as a pharmacodynamics study. These both showed that patients receiving the drug receive a sustained reduction of potassium in the blood.
Mene Pangalos, Executive Vice President for Biopharmaceuticals R&D at AstraZeneca, said: “This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia. Lokelma will offer the opportunity for patients and physicians to achieve long-term disease control and potentially reduce the risk of acute episodes, which can have serious, even life-threatening consequences.”
Lokelma has previously been approved in some of the world’s biggest markets. The US, EU and Canada have already approved the drug, with it going through a separate regulatory review in Japan which is expected to be completed in early 2020.
Lokelma is used to treat hyperkalaemia. This condition is characterised by high levels of potassium in the blood and can be fatal, sometimes leading to cardiac arrest and death.
Symptoms include muscle weakness, numbness, tingling and nausea, with it usually developing slowly over weeks or months. Common causes can be a diet high in potassium or kidney disease. Sometimes it can be a side effect from medication that keeps the kidneys from removing enough potassium.
Conor Kavanagh
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
