Business Wire

Galderma receives a positive outcome through the European Decentralised Procedure for AKLIEF® (trifarotene 50 mcg/g cream), the first new retinoid molecule for acne in the European Union in 25 years1

Share

Galderma today announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. Each of the 16 concerned member states will now issue individual national marketing authorisations for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Once approved, trifarotene 50 mcg/g cream will be the first new retinoid molecule launched in the European Union in 25 years.1

“Although retinoids are the cornerstone of acne treatment, there have been few significant advances or developments in decades,” said Professor Thomas Dirschka, University of Witten-Herdecke, Germany. “It is encouraging to see innovative approaches to tackling one of the most common and frustrating skin diseases.”

“Truncal acne can affect almost half of those with facial acne. It often goes under-reported and underdiagnosed, despite a desire from patients to have it treated,” said Professor Jerry Tan, University of Western Ontario, Windsor, ON, Canada. “To date, there has been a lack of scientific evidence on the management of truncal acne and as such, it is important to investigate new treatment options that specifically address this unmet need.”

Trifarotene 50 mcg/g cream is the first treatment to selectively target retinoic acid receptor gamma (RAR-γ), the most common RAR found in the skin.2,3,4 Trifarotene 50 mcg/g cream was assessed by regulators on data from two large, randomised Phase III clinical trials (PERFECT 1 & 2). Data have demonstrated that the systemic exposure of trifarotene 50 mcg/g cream is low as it is rapidly metabolised in the liver, with a half-life of just five minutes.3 Therefore, as well as treating facial acne, it can be used on large body surface areas of the trunk.3

“Acne can severely impact the quality of life and psychological well-being of those who suffer from it. The approval of AKLIEF® will provide patients across Europe with a next-generation retinoid cream that has been shown to be fast and effective at treating acne on both the face and trunk,” said Dr Thibaud Portal, Galderma Global Vice President of Prescription Medicines. “This underscores Galderma’s commitment to providing innovative solutions for the most common and frustrating skin diseases.”

Trifarotene 50 mcg/g cream has been shown to significantly reduce inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared with vehicle (control) (p<0.001).2 Trifarotene 50 mcg/g cream was well tolerated on the face and trunk. Treatment-related adverse events included mild-to-moderate application site reactions, such as skin irritation, mainly characterised by scaling, dryness, erythema and burning/stinging.2

-END-

About Acne
Acne is one of the most common skin disorders and affects approximately 70 million people across Europe.5 Acne can occur on the face and trunk (shoulders, back and chest)6,7 and it is estimated that around half of people with facial acne also have truncal acne.7 Despite the clear need for treatments that target both facial and truncal acne, there has been a lack of scientific evidence on the management of truncal acne, with the majority of studies focusing on the treatment of facial acne alone.8,9

About AKLIEF®
In the European Union, AKLIEF ® (trifarotene 50 mcg/g cream) is indicated for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. It is the only topical retinoid that specifically targets retinoic acid receptor gamma (RAR-γ), the most common RAR in the skin.3,4 National marketing authorisations across concerned European member states will follow in 2020.

AKLIEF ® received approval from the US Food and Drug Administration (FDA) in October 2019.10 It also received approval from Health Canada in November 2019.11

About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

References

  1. EMA. List of European Union reference dates frequency of submission of periodic safety update reports. Available at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs (Last access December 2019)
  2. Tan J, et al. J Am Acad Dermatol 2019;80(6):1691–9.
  3. Aubert J, et al. Br J Dermatol 2018;179:442–56.
  4. Fisher GJ, et al. J Biol Chem 1994;269(32):20629–35.
  5. Hay RJ, et al. J Invest Dermatol 2014;134(6 Suppl 1):S2.
  6. Dréno B, et al. J Eur Acad Dermatol Venereol 2015;291096-1106.
  7. Del Rosso JQ, et al. J Drugs Dermatol 2007;6(6):597–600.
  8. Liu CW & Tan J. Skin Therapy Lett 2017;12.
  9. Asai Y, et al. CMAJ 2016;188:118–26.
  10. FDA. Approval of Aklief. Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 (Last access December 2019)
  11. Health Canada. Approval of Aklief. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/register.html (Last access December 2019)

Contact information

Media Contact
Sébastien Cros
Head of Corporate Communications
media@galderma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Owl Labs Teams with Ingram Micro to Widen Distribution of the Meeting Owl Pro within Europe26.1.2021 11:00:00 EETPress release

Owl Labs, the award-winning leader in immersive and collaborative video conferencing technology and services, today announced an alliance with Ingram Micro, the world’s largest distributor and provider of technology services and solutions. The new distribution agreement expands Owl Labs’ reach across Europe and strengthens Owl Labs’ presence within key European markets. Through Owl Labs working relationship with Ingram Micro, Owl Labs will now be able to expand the reach and accessibility of its award-winning flagship product, the Meeting Owl Pro, to one centralised distribution warehouse in Straubing, Germany, and from that single point will support its supply chain into 17 distribution centers across Europe, trading across all 28 countries. Ingram Micro serves a diverse base of resellers and 2,000+ of the world’s most recognized IT and mobility technology brands. With the rapid adoption of hybrid work and remote teams, maintaining effective communication and collaboration regardless

MyHeritage julkaisee Värientisöinti-ominaisuuden tuomaan uutta eloa haalistuneisiin valokuviin26.1.2021 10:51:00 EETTiedote

MyHeritage, johtava maailmanlaajuinen palvelu menneisyytesi löytämiseen ja tulevaisuutesi vahvistamiseen, ilmoitti tänään haalistuneiden värivalokuvien entisöintiominaisuuden julkaisemisesta. Merkittävä parannus MyHeritagen edistyneeseen valokuvatyökalusarjaan, värientisöinti palauttaa haalistuneiden valokuvien alkuperäiset värit poikkeuksellisen hyvin tuloksin. Tämä lehdistötiedote sisältää multimediaa. Katso koko julkaisu täällä: https://www.businesswire.com/news/home/20210125005989/fi/ MyHeritage julkaisee Värientisöinti-ominaisuuden tuomaan uutta eloa haalistuneisiin valokuviin (Photo: Business Wire) Värientisöinti sopii hyvin vanhoille 1950 – 1990 lukujen, albumeihin tallennetuille värivalokuville, joiden kemia ei ole kestänyt aikaa haalistuttaen värit tai muuttanut ne keltaisiksi. Värientisöintiteknologia on lisensoitu yksinoikeudella DeOldify:lta ja sen ovat kehittäneet syväoppimisen asiantuntijat Jason Antic ja Dana Kelley. Teknologia on nyt integroitu MyHeritageen. Se palautta

Credence MedSystems Receives a Strategic Investment From One of the World’s Leading Pharmaceutical Companies26.1.2021 09:07:00 EETPress release

Credence MedSystems announced today that Novartis has made a strategic investment in the Company. The investment will advance ongoing development and scaling of Credence’s innovative drug delivery systems, with an initial focus on the Credence Companion® Safety Syringe System. With the investment in Credence, Novartis seeks to support its patients, caregivers, and healthcare professionals by enhancing the safety and user experience during administration of Novartis injectable medications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210125005138/en/ The Credence Companion allows pharmaceutical manufacturers to provide critical usability and safety features to their end-users. At the completion of the injection, the user receives end-of-dose cues indicating that the full dose has been delivered, and the needle automatically retracts into the syringe barrel. The enhanced usability can contribute to improved adherence, while

AGCO Announces Organizational Update26.1.2021 00:31:00 EETPress release

AGCO (NYSE: AGCO), a global leader in the design, manufacture and distribution of agricultural machinery and solutions, today announced intended changes and recent additions to its senior leadership team to further increase customer focus and strengthen investment in precision agriculture and digital solutions to maximize stakeholder value. Robert Crain will be the Senior Vice President leading the newly formed Customer Experience team charged with delivering the best end-to-end customer experience in the industry. Seth Crawford has joined the senior team in the new role of Senior Vice President, Precision Ag and Digital to reinforce AGCO’s commitment to delivering industry-leading, smart farming solutions. Following a successful, 22-year tenure at Deere & Company, Mr. Crawford joined AGCO in 2019 to lead its Fuse Connected Services and Technology division. Additionally, other members of the senior team will assume worldwide responsibility for AGCO’s core brands to maximize brand value

Mytheresa Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional American Depositary Shares26.1.2021 00:15:00 EETPress release

MYT Netherlands Parent B.V. (“Mytheresa” or the “Company”), the parent company of Mytheresa Group GmbH, today announced the closing of its initial public offering of 17,994,117 American Depositary Shares (“ADSs”), representing 17,994,117 ordinary shares, including the full exercise by the underwriters of their option to purchase 2,347,058 additional ADSs, representing 2,347,058 ordinary shares, at a public offering price of $26.00 per ADS. The Company sold 14,233,823 ADSs in the offering and its sole shareholder sold 3,760,294 ADSs in the offering, including 586,764 ADSs sold by the Company and 1,760,294 ADSs sold by the sole shareholder pursuant to the exercise in full of the underwriters’ option to purchase additional ADSs. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC acted as lead joint bookrunning managers and representatives of the underwriters for the offering. Credit Suisse Securities (USA) LLC and UBS Securities LLC acted as joint bookrunning managers for the offerin

UAEREP Launches Fourth Cycle and Starts Receiving Project Proposals25.1.2021 19:11:00 EETPress release

The UAE Research Program for Rain Enhancement Science (UAEREP) announced the launch of its fourth cycle at the fifth International Rain Enhancement Forum (IREF), convened virtually under the patronage of His Highness Sheikh Mansour bin Zayed Al Nahyan, UAE Deputy Prime Minister and Minister of Presidential Affairs. Submissions are open to innovative project proposals from across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210125005618/en/ UAEREP’s 4th Cycle Now Open! (Graphic: AETOSWire) The program offers a grant of up to US$1.5 million, distributed over three years with a maximum annual amount of $550,000 for each winning research proposal in the rain enhancement field. Over its past three cycles, the program has provided grants to nine ground-breaking projects that covered different fields related to rain enhancement and weather modification research. Interested academic institutions, research centers and ot

PPG Donates Coatings, Sealants to Help Restore Douglas C-54 Skymaster Aircraft25.1.2021 19:02:00 EETPress release

PPG (NYSE:PPG) today announced that it recently supplied coatings and sealants to help restore a 74-year-old, four-engine transport aircraft – the Douglas C-54 Skymaster, serial number 56498. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210125005599/en/ PPG today announced that it recently supplied coatings and sealants to help restore a 74-year-old, four-engine transport aircraft – the Douglas C-54 Skymaster, serial number 56498. (Photo: Business Wire) Manufactured in 1945, the aircraft was used by the U.S. Army Air Force as a workhorse to transport medical supplies, troops and military equipment during World War II, the Korean War and the Vietnam War. It left military service in 1973 and was flown as a sprayer from 1975 to 1985. After its first restoration was completed in 2002, the aircraft was flown to England to be featured in a film about the Berlin Airlift. The film was cancelled, and the C-54 Skymaster sat exposed

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom