Pharmaceutical company Galderma has announced that China’s National Medical Products Administration (NPA) has approved Relfydess (relabotulinumtoxinA) for the temporary improvement of moderate-to-severe glabellar lines in adults.
The approval is supported by a local phase III study in China and data from the global RElabotulinumtoxin Aesthetic Development study (READY) clinical trial programme.
The Chinese study was a randomised, double-blind, active- and placebo-controlled trial involving 605 adults. Of these, 359 received relabotulinumtoxinA, 63 received placebo and 183 received onabotulinumtoxinA. At month one, the composite responder rate was 72.4% in the relabotulinumtoxinA group, compared with 1.6% in the placebo group.
In the published READY-1 trial, 300 adults were randomised and 297 received treatment. 223 patients received relabotulinumtoxinA and 74 received placebo. The month-one primary-endpoint analysis included 199 participants in the treatment group and 67 in the placebo group. Rates of composite improvement of at least two grades from baseline were 82.9% and 0%, respectively. For this measure, both the investigator’s and participant’s assessments at maximum frown had to show an improvement of at least two grades from baseline.
In READY-1, 39% of treated participants reported an effect from day one. Treatment-related adverse events were reported in 3.6% of treated participants and were typically mild.
Flemming Ørnskov, chief executive officer at Galderma, commented, “The approval of Relfydess in China marks a significant milestone for Galderma and reinforces our commitment to bringing differentiated, science-based innovations to patients and healthcare professionals worldwide. With approvals in more than 35 markets globally, Relfydess continues to build strong momentum, and we are excited to now bring it to patients in China, one of the world's biggest and most dynamic aesthetics markets.”