June 29, 2007

CellCept Study Results Released

This past Wednesday, the results of a phase III study on CellCept – an intravenous medication used to treat lupus affecting the kidneys (lupus nephritis) – were released to the public. If the FDA were to approve this drug, it would be the first medication in more than 40 years to be approved as such. The prospect of this is extremely exciting!

The FDA, however, is holding CellCept to an extremely high standard of surpassing a similar drug – intravenous Cyclophosphamide (IVC) – in effectiveness in order to gain this approval. The 24 week induction phase results show that CellCept has equivalent effectiveness as IVC. One interesting fact to note: IVC has never received official FDA approval to treat lupus nephritis itself.

The Lupus Foundation of America is eager to see a subset analysis, and hopes the FDA will take into account the findings of such an analysis. Once that analysis is complete, it could be found that CellCept is associated with fewer serious or life-threatening infections, and hospitalizations (which plague IVC users).

IVC has been linked to a high incidence of infertility, and CellCept has not – which is very exciting news since lupus affects so many women of childbearing age! Also, an analysis of how CellCept affects those of African descent would be interesting to see, as IVC is known to be less effective for this population.

The results released Wednesday are only preliminary. We at the LFA look forward to further analysis of the data and will report this information as soon as it becomes available.

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