dm+d

Unassigned

New Medicines

AkliefAcne vulgaris

Information

Aklief
New molecular entity
Galderma
Galderma

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Oct 21Has been available in the US since Oct 2019. Company is not able to share plans for UK availability, although it does seem to be planned. No information available to suggest it has been launched elsewhere in Europe [12-14].
Dec 19Receives Marketing Authorisations in 16 EU states, including the UK, through the decentralised procedure; licensed indication will be "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." [10] The full list of states involved is Sweden (RMS), plus Belgium, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain and the United Kingdom [11].
Nov 19Galderma intends to launch trifarotene on the US market imminently (Nov 2019) [8].
Oct 19Approved in the US [7].

Feb 19: Filed in US. Application includes data from PIII PERFECT 1 and PERFECT 2 trials [5].


Nov 17: Galderma has completed a PIII trial in acne vulgaris (in children over 9 years of age, adolescents and adults) in the USA, Czech Republic, Germany, Hungary, Canada and Puerto Rico (NCT02566369). Results are awaited [3,4].


Feb 17: Galderma has completed two PIII trials for acne vulgaris (in children over 9 years of age, adolescents and adults) - one in the USA, Czech Republic, Germany and Hungary (NCT02189629), and another in the USA, Czech Republic, Hungary, Poland, Romania, Russia, Spain and Ukraine (NCT02556788). Results are awaited [3,4].

Category

A small molecule selective agonist of the gamma retinoic acid receptor.
Acne affects more than 80% of people at some point in their life, up to 14% of whom consult their GP and approximately 3.5 million consultations with GPs occur in the UK annually for acne. Morbidity can be high and associated with disfigurement, pain, loss of confidence, and impairment of normal social and workplace function, with documented effects on quality of life including depression, dysmorphobia, and suicide [1].
Acne vulgaris
Topical

Trial or other data

Nov 19A PIII trial is underway evaluating subject reported outcomes with use of trifarotene 50 μg/g cream in subjects with moderate facial and truncal acne vulgaris; the estimated primary completion date is January 2020 [8,9].

Feb 19: Results of PIII PERFECT 1 and PERFECT 2 trials of Trifarotene in patients with moderate facial and truncal acne are published in Journal of the American Academy of Dermatology. The two identical multicenter, randomized, 12-week clinical trials of more than 2,400 patients met all primary and secondary efficacy endpoints, including IGA (facial acne), changes in inflammatory and non-inflammatory lesion counts and Physician Global Assessment (PGA) - truncal acne [6].


Nov 15: PIII study (NCT02566369) to assess efficacy and safety of CD5789 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris begins. 1,200 patients aged 9 years and older will be recruited in the US. Primary outcome is success rate, defined as the percentage of subjects who achieve an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement. Collection of these data should complete Mar 17 [2].


Evidence based evaluations