WASHINGTON (dpa-AFX) - Galderma (GDERF) announced that China's National Medical Products Administration (NMPA) has approved Relfydess (relabotulinumtoxinA) for the temporary improvement of moderate-to-severe glabellar lines, commonly known as frown lines, in adults.
The approval expands the company's injectable aesthetics portfolio in one of the world's largest and fastest-growing aesthetic markets.
Frown lines are the vertical lines that appear between the eyebrows due to repeated facial expressions and aging. Neuromodulators are commonly used aesthetic treatments that temporarily relax targeted muscles to reduce the appearance of these lines.
Relfydess is the first and only reduce-to-use liquid neuromodulator developed with Galderma's PEARL Technology. Unlike products that require preparation before use, Relfydess is supplied in a liquid formulation designed for direct administration.
The approval was supported by data from a local Phase 3 study in China and Galderma's global READY clinical program, which included more than 2,300 participants. In the studies, Relfydess demonstrated significantly improvements in frown lines compared with placebo.
According to the company, 39% of patients in the READY-1 trial reported visible improvement as early as the first day after treatment. Results were also sustained, with up to 75% of patients maintaining improvements through six months in some analyses.
Relfydess demonstrated a favorable safety profile across clinical studies, with treatment-related adverse events primarily consisting of expected effects such as injection-site reactions, headache and eyelid drooping.
The China approval followed authorizations and launches of Relfydess in more than 35 markets worldwide, including the European Union, the United Kingdom and Australia.
Galderma said the approval strengthens its position in the Asia-Pacific aesthetics market and supports its strategy of expanding access to science-based aesthetic treatments globally.
GDERF has traded between $171.60 and $248.46 over the past year. The stock closed Thursday's trading at $220.14, up 10.82%.
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