Gilead Sciences, which already makes the leading hepatitis C drugs Harvoni and Sovaldi, recently received priority review from FDA for a new Hepatitis C combination drug.
The manufacturer is investigating a once-daily fixed-dose combination of Sovaldi and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
Here is what you need to know about the new drug, SOF/VEL:
1. FDA has set a target date of June 28, 2016, for final approval of the drug.
2. The new combination drug will likely boost revenues for Gilead, which has come under fire for Gilead and Harvoni’s high prices. Gilead has not yet released a price for SOF/ VEL, but executives will have to keep legislators’ and patients’ pricing concerns in mind. Sovaldi’s sales dropped a significant 48% to $1.47 billion during the third quarter. Harvoni only had a slight sales drop, from $3.61 billion to $3.33 billion during the same quarter.
3. The third major hepatitis C drug in Gilead’s portfolio would definitely help the company ward off competition from Abbie’s Viekira Pak. However, Merck and Bristol-Myers Squibb are also developing hepatitis C combination treatments.
4. FDA has assigned SOF/VEL a breakthrough therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four phase 3 trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6.
5. A marketing application for SOF/VEL is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in December.