Galderma has received approval from China’s National Medical Products Administration for Relfydess (relabotulinumtoxinA) for the temporary improvement of moderate-to-severe glabellar lines in adults.
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The decision is supported by a local Phase III study involving 605 adults, alongside data from the global READY clinical trial programme. In the Chinese study, 72.4% of patients treated with Relfydess achieved a composite response at one month, compared with 1.6% in the placebo group.
In the READY-1 trial, 82.9% of treated participants achieved at least a two-grade improvement at one month, compared with none in the placebo group. Some 39% of treated participants reported an effect from the first day, while treatment-related adverse events occurred in 3.6% and were typically mild.
The approval expands Relfydess’s presence in a key aesthetics market, adding China to the more than 35 markets where the product has received approval.
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