German powerhouse Bayer is to pull a formulation of its anti-infective Leukine (sargramostim) from the USA following a spike in the number of adverse events reported, particularly fainting and hypotension.
Bayer says that the rise in AEs corresponds to a formulation change to include edetate disodium, a chelator that is approved separately in the USA as an emergency treatment to combat high levels of calcium in the blood or heart rhythm problems following digitalis poisoning.
The firm says it now plans to reformulate the 500mcg vial – the only one to include EDTA – and will open a special access programme to enable patients with life threatening conditions preferential treatment using the 250mcg vial, which does not contain the substance in question.
Leukine is a growth factor designed to boost the immune system and combat infections in AML and transplantation patients.
It’s not been a good few months for Bayer in terms of drug recalls. Last year, the firm pulled its blood loss agent Trasylol (aprotinin) from the global market after a 3,000-patient study to reduce post-operative bleeding in heart failure patients found a higher risk of death amongst those given Trasylol compared with two older antifibrinolytic agents, epsilon-aminocaproic acid and tranexamic acid.
Priority review for Nexavar in Japan
However, it still has its sights firmly on the anticancer agent Nexavar (sorafenib) and has just won the priority review status in Japan to treat liver cancer. The company is looking to expand its product portfolio in the country and has also recently been granted the thumbs up for its liver contrast agent Primovist (gadoxetic acid disodium), which will be launched onto the Japanese market in the “immediate future” to diagnose liver tumours.
Japan has the second largest population of liver cancer patients in the world, the majority of which suffer from hepatocellular carcinoma; the indication being pursued by Bayer.
Nexavar is currently approved in more than 60 countries for advanced kidney cancer and is also being investigated in a wide range of other tumour types, including non-small cell lung cancer, breast cancer and metastatic melanoma. Indeed, data from a Phase III lung cancer trial should be available by the end of the year.
