Announcement • 14h

Allergan Aesthetics Receives Approval for Boey (Trenibotulinumtoxine) in Canada

Allergan Aesthetics, an AbbVie company, announced Health Canada has approved Boey (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows (glabellar lines) in adult patients. Boey is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved for the temporary improvement in the appearance of glabellar lines. Boey offers a differentiated treatment option for many people who are curious about facial injectables. Results may be seen as early as eight hours after treatment and typically wear off within approximately two to three weeks. BOTOX Cosmetic (onabotulinumtoxinA) is the only neurotoxin clinically tested for use following treatment with Boey. Boey was developed for patients offering a new way to experience neurotoxin treatment. Developed by the makers of BOTOX Cosmetic, Boey offers a new option for suitable patients considering facial injectables. Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey and is preparing for a commercial launch in the upcoming months as trenibotulinumtoxinE is under review for approval in multiple other countries. The approval of Boey is supported by data from two randomised, multi-centre, double-blind, placebo-controlled studies Phase 3 clinical trials evaluating the efficacy and safety of Boey in adults with moderate to severe glabellar lines (M21-500 and M21-508) associated with corrugator and/or procerus muscle activity. The studies enrolled 947 patients treated with Boey 700 U total dose or placebo. The primary efficacy measure was defined as the percentage of subjects achieving None or Mild and = 2-Grade Improvement from baseline in glabellar line severity at maximum frown based on both investigator and subject assessments using the Facial Wrinkle Scale (FWS) at Day 7. Efficacy was assessed in the ITT population. The composite responder rates at Day 7 were 60.0% and 65.7% (M2-500: n=289/482; M21-508: n=149/227; p<0.0001). Secondary efficacy endpoints were measured by Facial Line Satisfaction Questionnaire (FLSQ), a validated scale developed by Allergan Aesthetics, and included satisfaction with achieving a natural look and overall satisfaction with treatment effect. The onset of effect for patients treated with Boey appeared as early as 8 hours after injection in both pivotal studies. Glabellar lines returned to baseline severity in approximately 14-21 days after administration. The most frequently reported treatment-related adverse events were headache (3.4% in the Boey-treated group and 4.2% in the placebo-treated group), injection site pain (1.7% in the Boey-treated group and 2.9% in the placebo-treated group), and injection site erythema (0.6% in the Boey-treated group and 1.3% in the placebo-treated group). Boey is used in adults to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar/frown lines). Boey may cause serious side effects, including: Distant spread of toxin effects. It is possible that the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. Trouble breathing and trouble swallowing can be life threatening. One unit (amount) of Boey is NOT the same as one unit of other botulinum products. Boey should only be given by a trained healthcare professional. They should have experience using Boey. Follow the dose and schedule of injection recommended by your healthcare provider. Do not use Boey if you are allergic to botulinum toxin or any of the other ingredients or you have a skin infection where you plan to get the injection. To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Boey. Talk about any health conditions or problems you may have, including if you have allergies to any botulinum toxin product, had a side effect from any botulinum toxin product in the past, have had facial surgery or injured your face, are planning to have facial surgery soon, have any redness or swelling (inflammation) where you plan to get an injection, muscles where the injection will be given are weak, have drooping of one or both eyelids (ptosis), have any other change in the way your face normally looks, have certain diseases that affect your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy). Injection site reactions: Like with any injection procedure, injection site reactions may happen after receiving Boey. Symptoms at the injection site(s) may include pain/discomfort, swelling/inflammation, redness, bruising, bleeding, itching, warmth, hardness at the site where the needle entered your skin. Muscle weakness in areas next to or near the injection sites such as eyelid drooping and double vision (seeing two objects when there is only one). Driving and using machines: If you have drooping eyelids or problems with your vision after using Boey, do not drive or use machinery until those symptoms go away. After you get Boey, talk to your healthcare professional if you have the following: Allergic reaction: An allergic reaction is a reaction your body has to a medicine. This can cause symptoms such as hives, rash, or fever. Contact your healthcare professional right away if you have any of the symptoms listed as they can be signs of a severe allergic reaction: trouble breathing, swallowing, or speaking, swelling, including swelling of the face or throat, wheezing (a whistling sound while breathing), feeling dizzy or light-headed, shortness of breath. Distant spread of toxin effect: Sometimes, the effects of botulinum toxin may spread from the injection area to other parts of the body. Contact your healthcare provider right away if you have any of the symptoms listed: muscle weakness, trouble swallowing, unwanted food or liquid going into the airways. Reduced blinking or experience dryness in one or both eyes. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with Boey: a different medicine that has botulinum toxin, muscle relaxants (medicines that reduce muscle tension), antibiotics (medicines used to treat infections), anticholinergics (medicines that reduce muscle strength). Ask your healthcare provider for advice before you take any new medicines. Boey can have side effects, although not everybody gets them, including drooping eyelid (uncommon), drooping eyebrow (uncommon), or raising of the outer eyebrow (rare).

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