dm+d

Unassigned

New Medicines

Jublia (US)Onychomycosis

Information

Jublia (US)
New molecular entity
Almirall
Bausch Health Companies

Development and Regulatory status

None
None
Launched
Sep 21EU launches planned for 2023, depending on regulatory pathway [9].
Jul 21Almirall and Kaken enter into a license and distribution agreement in which Kaken Pharmaceutical grants Almirall the exclusive right for development and commercialisation of the topical formulation of efinaconazole in Europe. The product has been marketed in Japan since 2014 under the trade name of Clenafin®. It has also been launched in the United States, Canada, Korea, Taiwan, Hong Kong and Macau by Kaken Pharmaceutical’s partner companies under the trade name of Jublia. Almirall plans to have a pre-submission meeting with regulatory authorities within the next year to prepare the approval of the product in Europe [8].
Jan 15Paediatric Committee of EMA agreed a Paediatric Investigation Plan for efinaconazole for the treatment of onychomycosis. All studies are to be completed by 2018 [7].
Jun 14FDA has approved Jublia® (efinaconazole 10% topical solution) for the treatment of onychomycosis of the toenails [5]
Apr 14EU marketing plans uncertain. Only current activity in Japan, US, Canada.
May 13The FDA issued a Complete response letter citing questions on the container closure apparatus used during manufacture. The company anticipates responding soon to the issues raised. [4]
Mar 13Filed in US, Canada and Japan in 2012 [3].
Nov 12Valeant is investigating the safety and efficacy of efinaconazole 10% topical solution, the first triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). [1]

Category

Azole antifungal
UK prevalence studies report a range of 3-8%. Adults are ~30 times more likely than children to suffer the condition (affects 2.6% of children younger than 18 years, the figure in people over 60 is nearer 20%). [2,6]
Onychomycosis
Topical

Trial or other data

Nov 12Two Phase 3 RCTs conducted in pts with onychomycosis affecting at least one great toenail, with at least 20-50% involvement. Study 1 (n=870) and Study 2 (n=785) with treatment given in 3:1 ratio to efinaconazole 10% or vehicle, applied once-daily for 48 weeks with post-treatment follow-up at week 52. The primary endpoint was defined as the complete cure rate at Week 52, ie. the target nail showed no clinical involvement and no evidence of fungus present. In both studies, the primary endpoint was statistically significant (p<0.001) in favour of efinaconazole, with complete cure in Study 1 in 17.8% (efinaconazole) vs. 3.3% (vehicle). Corresponding proportions In Study 2 were 15.2% vs. 5.5%. Mycologic cure rates were also statistically significant (p<0.001) in favour of efinaconazole: Study 1, 55.2% (efinaconazole) vs. 16.8% (vehicle) and in Study 2, 53.4% vs. 16.9%. Healthy toenails can take 78 weeks to grow completely, so it is not surprising that mycologic cure rates were greater than complete cure rates. More patients treated with efinaconazole (Study 1: 26.4% and Study 2: 23.4%) achieved a complete or almost complete cure (≤5% clinical involvement and mycologic cure) vs. vehicle (Study 1: 7.0% and Study 2: 7.5%; both P <0.001). Adverse events were generally mild and transient and were similar between subjects treated with efinaconazole solution 10% and vehicle. Local site reactions were infrequently reported (e.g., dermatitis), and appeared to be more likely to occur with efinaconazole treatment (2%) [1]