MedPath

Xeomin Receives FDA Approval for Simultaneous Treatment of Upper Facial Lines

• Xeomin (incobotulinumtoxinA) gains FDA approval as the first and only neurotoxin for simultaneous treatment of forehead lines, frown lines, and crow’s feet. • The approval stems from Phase 3 trials demonstrating Xeomin's efficacy and safety, with high patient satisfaction and continued efficacy over multiple treatment cycles. • Xeomin's unique formulation, devoid of unnecessary proteins, minimizes the risk of immune response and ensures consistent results, appealing to patients seeking essential ingredients. • Merz Aesthetics expands its 'Beauty on Your Terms' campaign, targeting a younger audience and empowering them to embrace personalized aesthetic choices with Xeomin.

Merz Aesthetics announced that Xeomin (incobotulinumtoxinA) has received FDA approval as the first and only neurotoxin in the U.S. indicated for the simultaneous treatment of upper facial lines, including forehead lines, frown lines, and crow’s feet. This approval expands Xeomin's existing indication for glabellar lines, offering a comprehensive solution for upper facial aesthetics.

Clinical Trial Data

The FDA's decision was supported by data from two Phase 3 double-blind, placebo-controlled studies involving 730 adult participants. The studies demonstrated that Xeomin achieved a significantly higher response rate compared to placebo at Day 30 across all upper facial line areas. The simultaneous treatment was well-tolerated, with adverse events being mild to moderate, and no treatment-related serious adverse events were reported.

Unique Formulation

Xeomin distinguishes itself through its proprietary XTRACT Technology, which filters out unnecessary proteins, leaving only the essential ingredients for treatment. According to Patrick Urban, President, North America, Merz Aesthetics, 90% of surveyed patients prefer a neurotoxin treatment with only essential ingredients. This formulation minimizes the risk of immune response, which can lead to decreased efficacy, a concern reported by over one in three toxin users.

Expert Commentary

"Xeomin is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines)," said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. "This new indication for Xeomin proves we are moving the needle within the toxin space and meeting the needs of our consumers as it comes to efficacy and results, while containing only the essential ingredients needed for treatment."

Market Context

The approval aligns with Merz Aesthetics' 'Beauty on Your Terms' campaign, which aims to introduce Xeomin to a younger demographic. The campaign emphasizes personalized aesthetic choices and empowers individuals to embrace their own definitions of beauty. Demi Lovato, Xeomin brand partner, stated, "In my opinion and experience, Xeomin is the smart choice for treatment of my upper facial lines... The SmartTox formula is double filtered with only the ingredients essential for treatment to give me natural-looking results treatment after treatment."

Dosing and Administration

The total recommended Xeomin dose for the simultaneous treatment of upper facial lines is 64 units, divided as follows: 20 units for glabellar frown lines, 20 units for horizontal forehead lines, and 24 units for crow’s feet.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Cobenfy, a Novel Muscarinic Receptor-Targeting Drug for Schizophrenia

The FDA has approved Cobenfy (xanomeline-trospium), the first new mechanism of action in schizophrenia treatment in over 70 years, targeting muscarinic cholinergic receptors.
Cobenfy combines xanomeline, a muscarinic M1/M4 receptor agonist, with trospium, a pan-muscarinic antagonist, to mitigate peripheral side effects.

FDA Approves Minocycline Hydrochloride (Emrosi) for Rosacea

The FDA has approved minocycline hydrochloride extended-release capsules (Emrosi) for treating inflammatory lesions of rosacea in adults.
Phase III trials (MVOR-1 and MVOR-2) demonstrated that minocycline hydrochloride achieved significantly greater treatment success compared to doxycycline and placebo.

BOTOX® Cosmetic Receives FDA Approval for Platysma Bands

BOTOX® Cosmetic (onabotulinumtoxinA) gains FDA approval for temporarily improving the appearance of moderate to severe platysma bands in adults.
This approval expands BOTOX® Cosmetic's indications, making it the first and only product approved for forehead lines, frown lines, crow's feet, and platysma bands.

FDA Approves Botox Cosmetic for Platysma Bands, Expanding Aesthetic Applications

Botox Cosmetic receives FDA approval for improving the appearance of moderate to severe platysma bands in adults, marking its fourth aesthetic indication.
Clinical trials demonstrated statistically significant improvements in platysma band appearance with Botox Cosmetic compared to placebo (p<0.0001).

FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis

The FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) as a twice-yearly, 10-minute subcutaneous injection for both relapsing and primary-progressive multiple sclerosis.
Approval was based on the Phase III OCARINA II trial, which demonstrated equivalent drug levels, comparable safety, and high patient satisfaction compared to intravenous Ocrevus.

FDA Approves Roche's Ocrevus Zunovo for Multiple Sclerosis with Halozyme's Enhanze Technology

The FDA has approved Roche's Ocrevus Zunovo, a subcutaneous formulation for relapsing and primary progressive multiple sclerosis, utilizing Halozyme's Enhanze drug delivery technology.
Ocrevus Zunovo offers a twice-yearly, approximately ten-minute subcutaneous injection, providing greater flexibility for healthcare providers and patients based on individual needs.

FDA Approves Ocrevus ZUNOVO: First Subcutaneous Injection for Multiple Sclerosis

The FDA has approved Ocrevus ZUNOVO as the first and only twice-yearly, 10-minute subcutaneous injection for relapsing and primary progressive multiple sclerosis.
Ocrevus ZUNOVO offers an alternative administration method, potentially expanding treatment access to centers with IV constraints or limited infrastructure.

FDA Approves Roche's Ocrevus ZUNOVO for Relapsing and Progressive Multiple Sclerosis

The FDA has approved Ocrevus ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Ocrevus ZUNOVO is administered via a roughly 10-minute subcutaneous injection twice a year by a healthcare professional.

FDA Approves Subcutaneous Ocrelizumab (Ocrevus Zunovo) for Multiple Sclerosis

The FDA has approved subcutaneous ocrelizumab (Ocrevus Zunovo) for relapsing and primary progressive multiple sclerosis (MS).
Ocrevus Zunovo offers a new twice-yearly, 10-minute injection option, providing greater flexibility for patients and healthcare providers.

Fosun Pharma and MingMed Achieve Key Regulatory Milestones for Novel Therapies

Fosun Pharma's subsidiary, Jisimei Pharmaceutical, has received marketing approval in China for its Oxaliplatin Injection, a chemotherapeutic agent developed for cancer treatment.
MingMed Biotechnology's subsidiary, Claruvis Pharmaceutical, has secured FDA IND approval for YY003, a liquid formulation of recombinant Botulinum Toxin Type A (BoNT/A).

Reference News

[1]
Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines
drugs.com · Jul 23, 2024

Xeomin, first approved in 2011 for frown lines, now also treats forehead and crow's feet lines. It's the first FDA-appro...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy