Galderma’s Relfydess™ (RelabotulinumtoxinA) receives positive decision for use in Europe

Galderma announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for RelfydessTM (RelabotulinumtoxinA – previously referred to as QM1114).

Galderma

RelfydessTM is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. RelfydessTM also received a marketing authorization in Australia earlier this year.

RelfydessTM is developed and manufactured by Galderma. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months for frown lines and crow’s feet.3,4,7,8 It is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dose/volume.

About RelfydessTM (RelabotulinumtoxinA):

Pioneered by Galderma, RelfydessTM is the first and only ready-to-use liquid neuromodulator created with PEARLTM Technology that is designed to preserve molecule integrity.1,2 PEARLTM Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.1-4,7,8 RelfydessTM is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About the READY clinical trial program:

The READY (RElabotulinumtoxin Aesthetic Development StudY) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants.3-6 The READY trials investigated the safety, efficacy, rapidity of onset and/or durability of RelfydessTM for six months on:

Frown lines 
Crow’s feet 
Frown lines and crow’s feet when treated alone or simultaneously
Frown lines and crow’s feet when treated alone or simultaneously with up to four repeated injections over 52 weeks 

About Galderma:

Galderma (SIX: GALD) is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.

For more information: www.galderma.com.

Contact the company, Galderma


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