martes, 16 de octubre de 2012
SANOFI: Re_marcable acción en UK con Alemtuzumab
A pharmaceutical company stands accused of putting profit before patients after withdrawing a drug used in the treatment of a chronic debilitating disease – ahead of relaunching it at a price predicted to be up to 20 times higher.
Three of Britain's leading neurologists have written to the Health Secretary, Jeremy Hunt, to protest at Genzyme, part of the multinational drug company Sanofi, halting supplies of the drug alemtuzumab for multiple sclerosis.
The drug is currently licensed for the treatment of leukaemia. But it has been known for 20 years also to be effective in MS patients suffering from an aggressive form of the disease.
Neurologists have used the drug in these patients "off label" – prescribing it on their own initiative even though it was not licensed for multiple sclerosis – following encouraging results from a large placebo-controlled trial published in the New England Journal of Medicine in 1998. Alemtuzumab, which is given in two courses a year apart, costs markedly less than other drugs for multiple sclerosis to which it is thought to be superior – around £2,500.
Genzyme has now applied for a licence for the drug in multiple sclerosis to regulators in Europe and the US and is expected to relaunch it under the trade name, Lemtrada, at what could be many times its current price. In the meantime the company has withdrawn the drug from MS patients' off-label treatment, pending the granting of the licence, on the grounds that "any adverse event outside a clinical trial … may complicate the regulatory process".
Professor Zajicek said he had personally treated about 150 patients with the drug, and 400 to 500 had received it across the UK. "Many of us think it is the best drug for patients with aggressive MS in the early stages of the disease. It's the greedy behaviour of the drug company that upsets me. They are just trying to rebrand it and put the price up. It is morally corrupt." (Más)
Discontinuation of licensed supplies of alemtuzumab orcampath