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Press statement
| Date: | 15 Aug 2005 |
|---|---|
| Time: | 00:00 |
| Subject: | Aimspro |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
There has been a lot of publicity about Aimspro, but very little of it has been based on the results of formal clinical studies. Only one very small MHRA authorised trial has been completed (in 12 patients) and this was designed to study the effects of the drug in the treatment of visual impairment associated with optic neuritis. The results of the trial were disappointing.
In order for a company to obtain a licence to market a product such as Aimspro, information concerning its quality, safety and efficacy must be collected during properly controlled and authorised tests and trials and submitted to the appropriate regulatory authority for consideration. In this case that authority is the Medicines and Healthcare products Regulatory Agency (MHRA) or (for biological products) the European Medicines Agency. To date no such data concerning Aimspro have been submitted for consideration and the product remains unlicensed.
There is provision in UK legislation for unlicensed products to be manufactured by the holder of a manufacturer’s specials licence, in order to fulfil the special clinical needs of patients as determined by their doctors. The manufacturer nominated by the company that owns Aimspro is not currently able to meet the conditions necessary for the grant of such a licence.
The MHRA has provided a considerable amount of help and advice over the past two years on what the product’s owners need to do in order to obtain a licence to market it. Since early this year input from the Agency has been extended to potential manufacturers of Aimspro. The company has also been given advice on the use of alternative licensed manufacturers. The MHRA will continue to do all that it can to advise the company and its nominated manufacturers on manufacturing and licensing issues, but the speed with which the product can be made available to people with MS, and the product’s future, depend on how the company wishes to progress. For further clarification on this matter we suggest those interested should contact the company direct.
Notes to Editor
