Eight months ago, the FDA rejected Evolus’ cheaper version of Botox due to deficiencies in its manufacturing and chemical composition, but last Friday they gained approval. The product, known as Jeuveau, promises to retail at 20-25% cheaper than Botox, making it accessible to people with a tighter budget. Evolus is not only currently enjoying their product’s approval, but they’ve also seen a subsequent increase in their shares value.
When is Jeuveau available?
Evolus is planning to launch Jeuveau in the United States in Spring of 2019, meaning there’s not too long of a wait for consumers who are eagerly waiting to see what all the hype is about. Evolus has released a statement, saying “We are pleased to introduce Jeuveau, the first FDA approved neurotoxin dedicated to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology.”
Jeuveau is cheaper, but is it as good as Botox?
Ava Shamban, a clinical investigator and MD, was involved in testing Jeuveau’s effects and commented that it will “provide a compelling new treatment option for physicians and their aesthetic patients.” Jeuveau was put head-to-head against Botox in the TRANSPARENCY program, which involved over 2,100 patients globally, and met both primary and secondary endpoints, as well as having no reported serious adverse effects.
Shamban went on to add, “The comprehensive data set generated by Evolus through the TRANSPARENCY clinical program will give my peers the utmost level of confidence in providing Jeuveau to their patients. I look forward to incorporating Jeuveau into my aesthetic product offering.”
Further testing prior to FDA approval
Prior to FDA approval Jeuveau was tested in clinical trials from two US Phase III randomized, multi-center, double-blind and placebo-controlled studies. Jeuveau demonstrated efficacy when compared to the placebo for reducing the severity of frown lines, known as glabellar lines, based on agreement from both patient and physician at day 30. 67.5% of participants in one study and 70.4% in another met the primary endpoint, compared to just 1.2% and 1.3% in the placebo trials. This shows a significant difference, supporting that Jeuveau is effective, which is great news for Evolus.
Bad news for Allergan’s Botox
Following the FDA approval, Evolus Inc.’s shares have gained 12%, whereas Allergan’s Botox has dropped by 4%. In 2018 alone, Allergan generated $3.58 billion in sales from Botox, which was originally used for cosmetic treatments, but has evolved to have many medical applications, including relieving migraine symptoms, treating bladder dysfunction and reducing excessive sweating.
Allergan’s Botox has gone largely unchallenged until now, despite other companies bringing out similar products, but none had much of an impact. Allergan seem prepared for the challenge Evolus is bringing as they’ve prepared to double their spending on direct-to-consumer advertising, as well as expand their Botox sales force in a bid to keep Botox on top.
Jeuveau is great news for anyone who currently uses Botox as it gives them an additional option that may work better for them. Of course, the cheaper price will certainly tempt consumers, which may lead to Botox having to drop their prices to stay in competition.