Dr. Zisemmen brought us a Press Release today from Genzyme (the company that makes Lemtrada).
They are not going to appeal the denial in December 2013- rather they announced today that following constructive discussions with the FDA they plan to resubmit Lemtrada for US approval in the second quarter of this year (April to June timeline).
The Press Release did not indicate how long the process might be to approval.
They are seeking approval of Lemtrada "for the treatment of relapsing forms of MS". The re-submission will provide information to specifically address issues previously noted by the FDA in its December 27th 'Complete Response Letter'- ie the denial.
Good news for all US patients the wait will probably be long but it will be coming and maybe our insurance companies will pick up part of this tab!!
Good Luck to everyone!
They are not going to appeal the denial in December 2013- rather they announced today that following constructive discussions with the FDA they plan to resubmit Lemtrada for US approval in the second quarter of this year (April to June timeline).
The Press Release did not indicate how long the process might be to approval.
They are seeking approval of Lemtrada "for the treatment of relapsing forms of MS". The re-submission will provide information to specifically address issues previously noted by the FDA in its December 27th 'Complete Response Letter'- ie the denial.
Good news for all US patients the wait will probably be long but it will be coming and maybe our insurance companies will pick up part of this tab!!
Good Luck to everyone!