FDA issues another CRL, this one to LEO Pharma

Complete response letters (CRLs) seem to be coming thick and fast from the US Food and Drug Administration, the latest victim being Denmark’s dermatology specialist LEO Pharma.

As part of their review of the company’s Biologics License Application (BLA) for tralokinumab, an investigational therapy for adults with moderate-to-severe atopic dermatitis, has issued a CRL requesting additional data relating to a device component of tralokinumab. The FDA did not request any new data on the clinical efficacy or safety of the drug product formulation of tralokinumab.

“We are committed to bringing tralokinumab to the market to support the millions of US adults who live with uncontrolled moderate-to-severe atopic dermatitis. The FDA has not raised any questions to the clinical efficacy or safety of tralokinumab, but only requested additional data relating to a device component of the combination product. We will now work closely with the FDA to address their request and bring tralokinumab to the U.S. patients as quickly as possible,” said Jörg Möller, executive vice president, global R&D at LEO Pharma.