Teva and Active Biotech's new MS drug accepted for EMA review
19 July 2012 17:06 in Consumer Healthcare News
Teva and Active Biotech have announced that their new multiple sclerosis (MS) treatment laquinimod has been accepted for European regulatory review.
The European Medicines Agency (EMA) has completed the validation process for its marketing authorisation application of the drug, which is specified for use among relapsing-remitting MS patients.
A formal scientific review by the agency's Committee for Medicinal Products for Human Use will now begin, drawing on data collated during two phase III clinical trials involving more than 2,400 patients.
The acceptance of laquinimod for European review has triggered a milestone payment of $5 million (3.18 million pounds) from Active Biotech to Teva.
Additionally, the companies have pledged to continue to work alongside the Food and Drug Administration as they seek to maintain progress towards US regulatory approval of the compound.
Teva is already responsible for developing the blockbuster MS treatment Copaxone, which is expected to generate net sales of $3.8 billion this year.
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