AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines

–TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks. –If approved, TrenibotE will be the first neurotoxin of its kind available to patients.–Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program. , /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines. "The submission provides evidence of TrenibotE's differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category." New patients wanting to experience the aesthetic benefits of a neurotoxin cite "fear of looking unnatural" as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic. The BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the Phase 3 pivotal studies were previously shared. "Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment," said Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the Phase 3 studies. "Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX® Cosmetic." BOTOX® Cosmetic (onabotulinumtoxinA) Important Information Indications BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity- Moderate to severe lateral canthal lines associated with orbicularis oculi activity- Moderate to severe forehead lines associated with frontalis activity- Moderate to severe platysma bands associated with platysma muscle activity IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING WARNING: DISTANT SPREAD OF TOXIN EFFECTPostmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. CONTRAINDICATIONS BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. WARNINGS AND PRECAUTIONS Lack of Equivalency Between Botulinum Toxin ProductsThe potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method. Spread of Toxin Effect Please refer to Boxed Warning for Distant Spread of Toxin Effect. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur. Serious Adverse Reactions With Unapproved Use Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established. Hypersensitivity Reactions Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined. Cardiovascular System There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease. Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin. Dysphagia and Breathing Difficulties Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning). Preexisting Conditions at the Injection SiteUse caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Dry Eye in Patients Treated With BOTOX® CosmeticThere have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist. Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products. ADVERSE REACTIONS The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%). The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%). The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%). The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications. DRUG INTERACTIONS Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic. USE IN SPECIFIC POPULATIONS There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. For more information on BOTOX® Cosmetic, please see accompanying full Prescribing Information, including Boxed Warning and Medication Guide. US-FA-01754 10/24 About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines

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