The daclatasvir-sofosbuvir regimen for the treatment of genotype 1
hepatitis C patients was granted amended Breakthrough Therapy
Designation by U.S. Food and Drug Administration (FDA). In the beginning
of 2015, the FDA had planned to remove Breakthrough-Therapy Designation
for the daclatasvir-sofosbuvir treatment since other therapies were
available and had higher success for other genotypes. However, the FDA
revised its first decision and decided to continue the development of
this therapy for the genotype 1 hepatitis C patients addressed in ALLY-1
Trial due to its promising results.
Read more... Labels: ALLY-1, daclatasvir plus sofosbuvir, FDA breakthrough designation