How long does it take to repurpose a drug?

The alemtuzumab ultra-marathon is not over yet. What can we do to help American MSers? #MSBlog #MSResearch

"The history of alemtuzumab (formerly Campath-1H) is an interesting one and is an example of how long it can take to repurpose a drug. If you have the time I would recommend you watch this YouTube video or the article by ."

Geoff Hale and Herman Waldmann: From laboratory to clinic: the story of CAMPATH-1. Methods in Molecular Medicine vol 40, pp 243-266. 

"You will have noticed that the first laboratory work that led to alemtuzumab's discovery started in 1979 with the first MSer being treated with it in 1991 in Cambridge. The culmination of this work is the NICE appraisal below stating that Alemtuzumab is a cost-effective treatment for adults with active relapsing remitting disease; 23 years to repurpose. The cost of the drug is £7045 per vial, this equates to £35,225 for the 5-day course in year 1 and £21,135 for the second and subsequent courses. About 65% of alemtuzumab-treated MSers will need just 2 courses over 5-years, 25% 3 courses, 10% 4 courses and very few 5 courses. In addition to the cost of the drug there are all the costs associated with infusions, treatment of infusion reactions, monthly blood monitoring, annual MRI scans and the treatment of the autoimmune complications. A rough calculation suggest to me that alemtuzumab is similar, or possibly cheaper, than natalizumab. Are we able to start prescribing it? No. NHS England has to adopt the NICE appraisal, this usually takes 3 months and there is a remote possibility given the costs of the drug in the first year that they may restrict access to prevent a run on the bank. NHS England works on an annual budget and it will hope that not too many MSers have been warehoused for alemtuzumab treatment."

"I would like to reiterate that the current hypothesis is that alemtuzumab is working via rebooting the immune system. When it reboots there is evidence that it changes the regulatory networks of cells; it is been hypothesised that these changes are responsible for its action. I am not sure that this is necessarily the case. One hypothesis I have proposed is that it may be working via B cells. Why? When you line up all the highly effective therapies in MS the only cell that is common to the action of all of them is the B cell. This is why I am B cell man. Clearly more work on  the B-cell hypothesis is required."

"Once again we need to reflect on the pioneers and heroes responsible for alemtuzumab, in particular Professor Alastair Compston for trying it and Professor Alasdair Coles and his team for their perseverance. Then there is Genzyme who were bold and brave enough to take on the financial risk; the programme could easily have failed. Finally, last but not least, we need to thank the many investigators and MSers who participated in the clinical trial programme. The development of alemtuzumab for MS has been an ultra-marathon."

"The ultra-marathon is not over yet; American MSers don't have access to this drug in their own country and a large proportion of MSologists are reluctant to try alemtuzumab first-line. The latter is the biggest problem; the data is clear that MSers have the most to gain from alemtuzumab when it used as a first-line therapy and as early as possible after the onset of the disease. Alemtuzumab is the drug that under pins the early highly-effective treatment paradigm. Are you ready for alemtuzumab? It is a transformational therapy."

CoI: multiple

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