Manufacturing Issues Lead to CRL for Liquid Botulinum Toxin

The FDA has issued a complete response letter for Galderma’s biologics licensing application relabotulinumtoxinA (QM-1114) to treat patients with moderate-to-severe glabellar lines (frown lines) and moderate-to-severe lateral canthal lines (crow’s feet).

The agency indicted that there were issues items related to chemistry, manufacturing, and controls (CMC) processes and was not related to safety and efficacy.

Galderma officials said in a press release they have already identified changes to the manufacturing process and will also be seeking further guidance from the FDA.

RelabotulinumtoxinA is ready-to-use liquid botulinum toxin A with a proprietary strain. Company officials have said a liquid formulation would eliminate the variability associated with a product from reconstituted powder.

In June 2022, Galderma released results from two phase 3 trials. Both studies met their primary endpoints with significantly higher response than placebo after one month for both frown lines and crow’s feet. Results showed rapid onset of action with median response within two days with 39% of patients seeing results on day 1 for frown lines and 34% of patients seeing results on day 1 for crow’s feet. The treatment was well tolerated with all treatment-related adverse events mild-to-moderate and non-serious

The READY (RElabotulinumtoxin Aesthetic Development StudY) phase 3 clinical program is composed of four phase 3 clinical trials which enrolled more than 1,900 participants.

Galderma also released an update on its arbitration with Ipsen regarding the regulatory filing strategy for relabotulinumtoxinA and to differing views relating to which countries form part of Ipsen’s/Galderma’s territories under the agreement. Galderma remains responsible for development, regulatory filing and strategy, manufacturing, and commercialization. Regulatory approval submissions and issued certificates will be in the name of Ipsen.