Hoping to give Botox (Allergan) competition, pipeline neurotoxins wait for the FDA’s nod. One of those hopefuls – Evolus – recently resubmitted its Biologics License Application to the FDA for its lead product DWP-450 (prabotulinumtoxinA).
Evolus announced the resubmission for DWP-450 August 2. The FDA had declined DWP-450’s approval for glabellar line treatment in adults a few months earlier, when the government agency issued a Complete Response Letter indicating it needed more data.
The FDA didn’t note deficiencies related to clinical, nonclinical or safety matters with the pipeline neurotoxin. Rather, the FDA asked for information related to the company’s Chemistry, Manufacturing, and Controls (CMC) processes, according to Evolus Chief Medical Officer and Head of Research and Development Rui Avelar, M.D.
“Given the content of the [Complete Response Letter], we stated that we were confident in our ability to respond to all the deficiencies and guided that we would be able to resubmit our Biologics License Application with all the deficiencies addressed within 90 days of having received the [Complete Response Letter]. On August 2nd, we announced that we did resubmit our [Biologics License Application] in response to the [Complete Response Letter] ahead of our guided timeline,” Dr. Avelar stated in an email provided by a public relations agency.
Evolus President and Chief Executive Officer David Moatazedi said in a company press release that the submission gives Evolus “a line of sight to the anticipated approval and subsequent commercialization of DWP-450.” The product’s planned commercial launch in spring 2019 still seems on track, according to Moatazedi.
PrabotulinumtoxinA is a 900 kilodalton purified botulinum toxin type A complex, according to Evolus.
In other pipeline neurotoxin news, Bonti announced positive early results on its novel botulinum neurotoxin serotype E (BoNT/E) product EB-001A.
In early August, Bonti announced in a press release: “EB-001 demonstrated dose-dependent clinical activity and efficacy at multiple doses. At the high dose cohorts, a 2-point response (assessed by the investigator) was observed within 24 hours of injection. At the two high doses, a 2-point response was reported in 80% of EB-001 subjects and in 14% of the placebo group. The duration of clinical effect was two to four weeks post-injection in the high dose groups.”
The privately-held company announced August 24 that neurotoxin pioneer Jean Carruthers, M.D., presented on EB-001A at the 5th Annual Masters of Aesthetics Symposium in San Diego. Dr. Carruthers is a Bonti medical advisor.
EB-001A, is being developed for glabellar frown lines and scar reduction following Mohs surgery, according to the release.