EMA grants Krystal Biotech Gene Therapy KB103 for treatment of large herpes epidermal softos

recently, krystal Biotechcompany(http:// announcedthat the EuropeanMedicines(http://Authority (EMA) has granted its leading candidate gene therapy KB103 (bercolagene telserpavec) prioritydrug(http://eligibility (PRIME)in the United States,FDA(http://has granted KB103 fast-track eligibility for treatment deB and orphan drug eligibilityAbout KB103
KB103 is the first local administration gene therapy developed for DEB treatmentThis PRIME qualification is based on GEM-1 data and non-clinical data for Phase I/II clinical studiesPRIME is a rapid approval program launched by EMA in March 2016, similar to the FDA's Breakthrough Drug Qualification (BTD) program, which aims to accelerate the review process of key drugs in theof(http://of, and the finalists will receive strong support from THE of clinicaltrial
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the unitedPrime-qualified drugs must have preliminary clinical evidence and non-clinical evidence that the drug can substantially improve the condition compared to existing therapeutic drugsKB103 is a replication-defective, non-integrated viral vector that uses Krystal's proprietary skin target delivery platform STAR-D development to deliver functional human COL7A1 genes directly to patient splinter and non-dividing skin cellsHSV-1 is A replica, non-integrated viral vector of Krystal that penetrates skin cells more effectively than other viral vectors, and has a high effective load capacity that can accommodate large genes or multiple genes, in addition, the carrier's low immunogenicity makes it an appropriate choice for direct and repeated delivery to the skin