Biotechnology company Revance Therapeutics, Inc. (Newark, Calif.) recently published the results of two pivotal trials of the company's neurotoxin drug candidate DaxibotulinumtoxinA for Injection (RT002), intended for the treatment of moderate to severe glabellar lines in adults. Based on these study findings, Revance announced that it expects U.S. FDA approval in 2019 and approval in Europe in 2021.
As revealed in the study results, RT002 incorporates Revance’s proprietary TransMTS®, an investigational injectable formulation designed to restrict daxibotulinumtoxinA to the target site.
As toxin-bound TransMTS peptides enter the muscle, they are thought to exert a focused effect at the injection site, thereby reducing the undesirable spread of toxin material and also potentially enabling longer duration. RT002’s peptide technology delivered positive top-line results in the firm’s recently completed SAKURA 3 Phase 3 open-label, long-term safety study.
The SAKURA-3 study included 2,700 patients and 3,800 injections, with results that indicated RT002, which will get its own distinctive brand name prior to anticipated agency approval, will be quite different from other aesthetic neurotoxin products currently on the market. Incidentally, the company is feeling very confident about RT002, and has already been touting it as a longer period neurotoxin treatment that may lead to dosing up to six months and possibly longer.
The next milestone for Revance will be studies to be completed in 2019 covering the use of RT002 in the forehead and lateral canthal lines, as well as its use and dosage in the upper face. The latter trial will employ what is apparently the largest database ever assembled for a neurotoxin study, with nearly 3,000 patients under multiple re-treatments. Revance is projected to publish topline findings of these study results in the first half of 2019 and then file a Biologics License Application (BLA).
According to company leadership, the marketplace for neurotoxins, which is dominated by Allergan’s Botox Cosmetic, could benefit from a product that provides a longer-duration effect.
According to a recent survey of more than 2,000 women by The Harris Poll, facial lines and wrinkles are the most concerning visible sign of aging among women aged 25 to 70. The survey also incorporated the observations and opinions of nearly 250 dermatologists and plastic surgeons who see at least 15 patients per week that come in for neurotoxin treatments. Among this group of physicians, a large majority stated they would like to have a neurotoxin product that offered longer-lasting results than what is currently available.
Throughout 2019, Revance will also actively pursue studies that are expected to generate approvals in Europe and Asia, as well as in Latin America, primarily in Brazil and Argentina. The company’s aggressive development program will reportedly add another territory every couple of quarters.