Relfydess earns positive opinion for treatment of frown lines, crow’s feet in EU
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Key takeaways:
- Relfydess has received a positive decision for treatment of frown lines and crow’s feet in the European Union.
- The decision was based on phase 3 results from the READY program.
Galderma has received a positive decision for Relfydess in the European Union following the company’s completion of its European decentralized procedure, according to a company press release.
Relfydess (relabotulinumtoxinA, Galderma) is indicated for the treatment of moderate to severe glabellar lines and lateral canthal lines, also known as frown lines and crow’s feet, in adults aged younger than 65 years who suffer from psychological distress from these wrinkles.
Now that the decentralized procedure has been completed, the company awaits national approvals from 16 European countries.
“With Relfydess, Galderma is introducing a highly differentiated and innovative neuromodulator, reinforcing our leadership and strong growth in this field, and our commitment to developing and delivering the broadest portfolio in injectable aesthetics,” Flemming Ørnskov, MD, MPH, CEO of Galderma, said in the release. “As per the decentralized European approach, our teams are now finalizing the approval procedures at the country level, so we’re ready to launch in multiple markets early next year.”
The decision was supported by the phase 3 READY program. The READY 1 and READY 2 trials showed that Relfydess exhibited a none-or-mild responder rate of 96.3% for frown lines and 87.2% for crow’s feet after 1 month of treatment vs. 4.5% and 11.9% with placebo, respectively.
According to the release, Relfydess is the first and only ready-to-use liquid neuromodulator, which does not require reconstitution, created with PEARL technology. Up to 39% of patients treated with Relfydess reported positive effects from day 1, with 75% of patients also reporting improvements that lasted 6 months.
According to the release, regulatory applications for Relfydess in these indications will continue to be submitted and assessed by additional authorities globally.
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