FDA issues complete response letter for relabotulinumtoxinA for frown lines, crow’s feet

Key takeaways:

• The FDA issued a complete response letter to Galderma for the biologics license application for relabotulinumtoxinA.
• The letter cited chemistry, manufacturing and control deficiencies.

The FDA has issued a complete response letter for Galderma’s QM-1114 biologics license application for the treatment of moderate to severe frown lines and crow’s feet, according to a manufacturer-issued press release.

The letter cites deficiencies related to the chemistry, manufacturing and control processes of the drug, according to the release. Issues related to safety and efficacy were not a concern.

The biologics license application for QM-1114 (relabotulinumtoxinA), a novel botulinum toxin A liquid formulation, was submitted to treat adults with moderate to severe glabellar lines, which are associated with corrugator and/or procerus muscle activity, and canthal lines, linked to orbicularis oculi muscle activity.

Galderma reports that it has already identified manufacturing changes that need to be made. The company further reported it will continue communicating with the FDA in order to resolve issues and move toward QM-1114 approval.