GlaxoSmithKline's Volibris drug receives positive recommendation
A committee of the European Medicines Agency (EMA) has recommended GlaxoSmithKline’s Volibris drug be approved for use in combination treatment for patients with pulmonary arterial hypertension.
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The Committee for Medicinal Products for Human Use (CHMP) announced the formal recommendation on Friday to expand the existing marketing authorisation.
The use of the drug will still need to be approved by the European Commission by December.
“Today’s decision represents an important milestone for the PAH community, supporting the potential for initial combination treatment in this highly debilitating and limiting disease,” said GSK’s Jonathan Langley.
“If approved, this could help improve clinical outcomes for patients across Europe suffering from this rare condition.”