A further blow for reformulated lung disorder therapy

The US regulator has turned down a submission from North Carolina, USA-based Liquidia Technologies to market LIQ861 (treprostinil) for pulmonary arterial hypertension (PAH).

A Complete Response Letter (CRL) from the US Food and Drug Administration identified the need for additional information and clarification on chemistry, manufacturing and controls (CMC) data pertaining to the drug product and device biocompatibility.

Liquidia, part of the publicly-owned Liquidia Corporation (Nasdaq: LQDA), said it “does not believe that the items raised in the CRL will be a barrier to ultimate approval.”