FDA starts review of oral formulation for Sobi's rare disease drug

Swedish Orphan Biovitrum AB (STO: SOBI) on Thursday said the US Food and Drug Administration (FDA) has started a review of the oral suspension formulation of Orfadin (nitisinone) to treat rare genetic condition.

The company said the dossier was submitted to FDA in June and a formal decision is expected during the second quarter 2016.

The oral suspension of Orfadin, if approved, will facilitate dosing accuracy and will simplify ease of use by reducing the number of steps required to administer the medicine, the company said in a statement.