SERONO SEEKS APPROVAL FOR REBIF FORMULATION

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Serono has filed with U.S. and European regulators for approval for a new formulation of its Rebif multiple sclerosis drug after a late-stage trial showed it is more tolerable than an earlier formulation of the drug.

Serono said it filed a supplemental biologics license application with the FDA to amend its 2002 approval of Rebif. The company also petitioned the European Medicines Agency to amend its Rebif marketing authorization in the EU, initially granted in 1998.