Lack of response speaks volumes on suspected PML case.
Yesterday, media reports indicated that a fifth suspected case of PML was reported through the FDA's Adverse Event Reporting System on 16 May. Potentially prescribed Tysabri rather than in clinical trails, the patient was apparently on dual therapy of Tysabri plus Avonex and was also on four other drugs including Cellcept.
This drug is commonly given to transplant patients and carries a black box warning on its immunosuppressive side-effects, which can lead to increased susceptibility to infection and the possible development of lymphoma.
(i) that the suspected case was reported a month ago;
(ii) that no statement has been released by either Elan or Biogen Idec on the case; and
(iii) the level of corporate activity and tenor of public statements by Elan over the past month while knowing of this case,
we continue to believe from the information currently available that this, along with the fourth suspected case, is not deemed material to the progress of Tysabri through the review process.
It is understandable that, after the withdrawal of Tysabri from the market, prescribing physicians will be extremely cautious. As such, they will be more likely to report any abnormalities in patients that were on Tysabri to the FDA.
We believe, therefore, that there may be a number of such reports in the system that could come out under the disclosure of information act over the coming months. However, it is not the existence of such reports that is material, rather Elan and Biogen Idec's response. As such, under current regulatory conditions, we believe the market will be informed of material events, if any, in the Tysabri review by the companies well before it is "revealed" through freedom of information channels.