Galderma wearing frown after relabotulinumtoxinA CRL

Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA).

The FDA has issued a Complete Response Letter (CRL) to Galderma regarding the BLA for relabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines, or frown lines, associated with corrugator or procerus muscle activity as well as moderate-to-severe lateral canthal lines, known as crow’s feet, associated with orbicularis oculi muscle activity.

Discussions with FDA