Date: 2014-07-08
Type of information: Granting of a Market Authorisation in the US
Product name: Kerydin™
Compound: tavaborole
Therapeutic area: Infectious diseases - Dermatological diseases
Action mechanism: Kerydin™(tavaborole) topical solution, 5%, is the first oxaborole antifungal agent developed for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Company: Anacor Pharmaceuticals (USA - CA)
Disease: onychomycosis of the toenails
Latest news: * On July 8, 2014, Anacor Pharmaceuticals announced that the FDA has approved the New Drug Application for Kerydin™ (tavaborole) topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. Kerydin™(tavaborole) is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. Debridement of the nail is not required during the treatment period. Due to its topical application, Kerydin™ has low systemic absorption and has not demonstrated systemic side effects. The efficacy and safety of Kerydin™ was evaluated in two multicenter, double-blind, randomized, vehicle-controlled trials. Kerydin™ or vehicle was applied once daily for 48 weeks in subjects with 20% to 60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. A total of 1194 subjects (795 Kerydin™, 399 Vehicle) 18 to 88 years of age, participated in these two trials. Efficacy assessments were made at 52 weeks following a 48-week treatment period. The primary efficacy endpoint was \"Complete Cure\" at Week 52. \"Complete Cure\" is defined as \"Completely Clear Nail\" (0% clinical involvement of the target toenail) plus \"Mycological Cure\" (negative KOH wet mount and negative fungal culture). In the first trial, 6.5% of subjects treated with KERYDIN reached the primary endpoint, compared to 0.5% of subjects treated with vehicle. In the second trial, 9.1% of subjects treated with Kerydin™ reached the primary endpoint, compared to 1.5% of subjects treated with vehicle. Secondary endpoints in the pivotal trials included \"Complete or Almost Complete Cure\" (less than or equal to 10% affected target toenail area involved plus \"Mycological Cure\") and \"Mycological Cure.\" 15.3% and 17.9% of patients treated with Kerydin™ achieved \"Complete or Almost Complete Cure\" compared to 1.5% and 3.9% of patients treated with vehicle in the first and second trials, respectively. 31.1% and 35.9% of patients treated with Kerydin™ achieved \"Mycological Cure\" compared to 7.2% and 12.2% of patients treated with vehicle in the first and second trials, respectively. Common adverse reactions occurring in at least 1% of subjects treated with Kerydin™ included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-07-08
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: * On July 21, 2014, Sandoz announced an agreement with Anacor Pharmaceuticals. to obtain exclusive rights to commercialize Anacor’s drug Kerydin™ (tavaborole) topical solution, 5% in the US, through its branded dermatology business, PharmaDerm.The agreement was effective July 18, 2014.
