In April, Gilead Sciences announced that the FDA granted a priority review to its new drug application for combination ledipasvir and sofosbuvir to treat chronic hepatitis C virus infection genotype 1 infection.
The application includes expedited review of a once-daily, fixed-dose tablet combination of 90 mg ledipasvir, a NS5A inhibitor, and 400 mg sofosbuvir, a polymerase inhibitor, to treat HCV in adults for 8 to 12 weeks. Gilead submitted data from three phase 3 studies — ION-1, ION-2 and ION-3. Treatment will be based on patients’ prior treatment histories and the presence of cirrhosis, according to a press release.
The FDA also assigned combination ledipasvir and sofosbuvir a breakthrough therapy designation, which gives priority review status to medicines that may offer major treatment advances.
The same month, AbbVie announced submission of a new drug application to the FDA for its fixed-dose combination of ABT-450/ritonavir at 150/100 mg coformulated with 25 mg ombitasvir (ABT-267), dosed once daily, and 250 mg dasabuvir (ABT-333) with or without weight-based ribavirin, dosed twice daily. The therapy is intended for the treatment of adults with chronic HCV genotype 1 infection, according to a press release.
Six phase 3 studies of this combination therapy were conducted in more than 2,300 patients in 25 countries. The FDA assigned this combination a breakthrough designation in May 2013.