November 18, 2020
- Dysport®is a prescription injection for temporary improvement in the look of moderate to severe glabellar lines – the first new muscle relaxant approved in China for eight years
- 95% of patients achieved high levels of satisfaction with two treatments per year, and a recent study in China confirmed its efficacy in the treatment of glabellar lines in Chinese female and male subjects
Lausanne, Switzerland – November 18, 2020 – Galderma today announced that it is launching Dysport® (abobotulinumtoxinA) in China at the end of year.
Dysport® (abobotulinumtoxinA) has received approval from the National Medical Products Administration of China (NMPA), making it the first new muscle relaxant approved for treatment of glabellar lines in China for eight years.
“We are thrilled to now be able to bring Dysport® to our Chinese customers and consumers thus underscoring our commitment to growing the aesthetic market and continuing to bring further innovation to this important market so that patients can embrace injections with confidence,” said Alexandre Brennan, Global Business Unit Head Aesthetics, Galderma.
In the recently announced DREAM study1 that evaluated patient satisfaction and safety with a twice-yearly treatment schedule, Dysport® showed top-line results with 95% of patients treated expressing high levels of satisfaction with two treatments per year, and 97% of patients thinking the result of the treatment looked natural.1
“The aesthetics market in China is particularly dynamic and continues to enjoy significant growth,” said Olivia Brown, General Manager, Greater China Region for Galderma. “Having only recently announced three new filler approvals for China, we’re delighted to further strengthen our medical aesthetics portfolio with Dysport®, which has gained the trust of customers and patients across the globe since its initial launch as a therapeutic option over three decades ago. We’re especially excited about the even greater choice of treatment options we can now offer our customers in China by the end of the year”.
The approval was based on a phase 3, randomized double blind and open label phase, multicenter active and placebo-controlled study that enrolled 520 Chinese subjects who were between 18 to 65 years of age. The objective was to investigate the efficacy and safety of Dysport® (abobotulinumtoxinA) including a non-inferiority comparison to onabotulinumtoxinA, as requested by the NMPA, in the treatment of glabellar lines, and to assess the long-term efficacy and safety of Dysport following repeated treatments. Overall, Dysport® 50 U was shown to be effective in the treatment of glabellar lines in Chinese female and male subjects and to have a favorable benefit-risk profile.
“I am excited about this toxin product, Dysport® now coming to our market,” said Dr. WU Yan, M.D., a board-certified and trained dermatologist at Peking University First Hospital in Beijing, China, and an investigator for the clinical study. “Our study showed that the median time to onset for Dysport was 2 days and in some patients the treatment was effective up to 6 months duration after injection, results which are of particular interest to my patients.”
The launch event for Dysport in China on November 18 will gather over 400 CEOs, COOs and HCPs from the most prominent companies in the aesthetics business in China and will feature speakers such as Prof. Xiang Lei Hong (Hua Shan Hospital, Fu Dan University), Dr. Luo Sheng Kang (The 2nd hospital of Guangdong Province).
About Galderma’s collaboration with Ipsen
Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport® is also marketed as Azzalure® in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.
Dysport® is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen’s botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport® within certain therapeutic indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.
Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com.
The Dysport® trademark is used under license. All trademarks are the property of their respective owners.
For further information:
Investor and media relations
Christian Marcoux, M.Sc.
Chief Communications Officer
+41 21 642 71 99
Isabella Laihorinne Smedh
PR & Communications, Galderma
- Data on file. Study 43USD1802. Galderma, Uppsala, 2020.
- Data on file. Galderma, Uppsala, 2020.