Biogen Idec has received clearance from the Australian authorities of health for the placing on the market Fampyra, treatment against multiple sclerosis (MS).
The biotech group said it had filed a parallel application for authorization for reimbursement from the Australian pharmaceutical benefits scheme.
Pending the outcome of this reimbursement procedure, Fampyra should be available to patients by prescription in October 2011.
In two Phase III clinical trials, the Fampyra showed a gradual improvement in "speed walk" - the indicator considered most relevant for evaluating the disease - compared to placebo (34.8% cons 8.3% and 42.9% against 9.3% respectively).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) was issued in January an unfavorable opinion on the drug.
Biogen Idec had expressed his intention to contest the notice and request reconsideration of the decision by the CHMP.
The biotech group said it had filed a parallel application for authorization for reimbursement from the Australian pharmaceutical benefits scheme.
Pending the outcome of this reimbursement procedure, Fampyra should be available to patients by prescription in October 2011.
In two Phase III clinical trials, the Fampyra showed a gradual improvement in "speed walk" - the indicator considered most relevant for evaluating the disease - compared to placebo (34.8% cons 8.3% and 42.9% against 9.3% respectively).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) was issued in January an unfavorable opinion on the drug.
Biogen Idec had expressed his intention to contest the notice and request reconsideration of the decision by the CHMP.