The Aimspro saga, like Tysabri, has taken many twists and turns in the past year. After posting promising anecdotal stories and interesting (though not overwhelming) trial results in the treatment of optic neuritis, the Medicines and Healthcare Products Regulation Agency (UK) seemed to have put a halt on production of the therapy. Today, the MHpRA released an update noting some interesting points:
- The agency had not put the production of Aimspro on hold, as previously reported in the press
- The agency had advised Daval International, makers of Aimspro, on how to obtain the appropriate licenses to produce Aimspro as a "special clinical need"
- The agency even pointed Daval to manufacturers who were skilled in the production of these so-called "special" therapies
- The agency is apparently trying to expedite the manufacture of Aimspro, but Daval is in control of the pace.
The first point seems rather confusing-- the agency did not put the production of the medicine on hold, but instead seems to have pointed (and enforced?) the series of licenses necessary to produce a biological agent safely.
In any case, the bottom line is that Aimspro is NOT dead, the regulatory agency seems actively involved in helping it be produced successfully and legally, and it is Daval that will be driving the pace of progress.
Click "read more" to get the full press release from the MHpRA.
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Link to Press Release
http://www.mhra.gov.uk/news/Aimspro_update060705.pdf
