Galderma wins FDA approval for new retinoid molecule acne treatment AKLIEF
pharmafile | October 7, 2019 | News story | Sales and Marketing |
Galderma, a global leader in skin health, has announced that the FDA has approved the First New Retinoid Molecule for the treatment of acne in over 20 years – Aklief (trifarotene).
Aklief Cream is now the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Aklief is also the first topical treatment specifically studied and proven to treat both facial and truncal acne thereby offering health professionals and acne patients another treatment option.
Sandra Johnson, an investigator in the clinical trials of Aklief and dermatologist at Johnson Dermatology, Arkansas, said: “While retinoids are foundation therapies to treat acne, there has been little innovation in decades.
“With the approval of Aklief Cream I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders that has also been shown to be safe and well-tolerated.”
The FDA approval for Aklief comes on the back of data from two pivotal Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk utilising 2,420 patients.
Thibaud Portal, Global Vice President at Galderma, said: “The approval of Aklief Cream underscores our ability to bring new active molecules to the community and innovate even in well-established therapeutic classes.
“It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne.”
Aklief Cream is expected to be available in the United States in November this year and will be provisioned as a 45 gram pump. Galderma is currently working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to Aklief Cream.
Nik Kiran
