July 1, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the European Commission has approved an update of the Summary of Product Characteristics (SPC) for Raptiva® (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis, a chronic inflammatory systemic disease of the skin. The decision followed a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which had previously completed a benefit-risk re-assessment of Raptiva®. The CHMP had concluded, based on the clinical and post-marketing data submitted by Merck Serono, that the benefit-risk profile remains positive for the population in the approved indication.
The details can be read here.
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