EMEA grants Surfaxin orphan status

The European Medicines Evaluation Agency has awarded DiscoveryLaboratories orphan drug status, and thus 10 years marketing exclusivity, for its humanized peptide-containing lung surfactant, Surfaxin (lucinactant), for the treatment of meconium aspiration syndrome in full-term newborns, a disease for which there is currently no approved treatment.

A recent Phase II clinical trial has shown that Surfaxin-lavaged newborns had a more rapid and consistent improvement in oxygenation compared to patients who had been treated with standard mechanical ventilation. Also, patients treated with the drug were weaned off the mechanical ventilator approximately three days sooner than those receiving standard care. The product was previously granted orphan drug status by the US Food and Drug Administration for the same indication, as well as for idiopathic respiratory distress syndrome in premature newborns and acute respiratory distress syndrome in adults.