The Food and Drug Administration (FDA) has approved Jeuveau, a botulinum toxin type A, for the temporary improvement in the appearance of moderate to severe glabellar lines.
Jeuveau is manufactured by the US-based medical aesthetic company Evolus Inc and is the company’s first and only product. The FDA approval was supported by clinical data from US Phase III randomised, multi-centre, double-blind placebo-controlled clinical trials.It was reported that 67.5% of subjects in study one and 70.4% of subjects in study two met the primary endpoint, compared to 1.2% and 1.3% of patients in each placebo arm respectively.
David Moatazedi, president and chief executive officer of Evolus, stated, “Evolus is the first company in nearly a decade to enter the fast-growing US aesthetic neurotoxin market. What makes Evolus unique is our focus on delivering performance beauty products with a customer-centric approach. We are pleased to introduce Jeuveau, the first FDA approved neurotoxin dedicated to aesthetics.”
Mr Dalvi Humzah, consultant plastic, reconstructive and aesthetic surgeon said he welcomes the introduction of a new toxin to the market. “I think the FDA approval of Jeuveau is good news for the aesthetic specialty. Having another toxin on the market will encourage good competition and further the development in this area, which is only a good thing. I would urge practitioners who are interested in using this new product to become fully aware of the pharmacology before treating their patients.”
Juveau is expected to be available through the US from Spring 2019. However, since the FDA approval, it has been reported that global pharmaceutical company Allergan is seeking to block imports of the rival treatment, claiming it was developed by former employees and therefore includes various manufacturing secrets.