FDA approves JNJ's Olysio in combo with Sovadi for hep C treatment
- The FDA has approved Olysio (simeprevir) for use in combination with Gilead's Sovaldi (sofosbuvir) for the treatment of hepatitis C. This is the second available all-oral treatment option for patients with hepatitis C (HCV).
- Johnson & Johson (J&J) has priced the drug at $66,000 for a 12-week course.
- J&J is selling Olysio in conjunction with the Swedish company, Medivir.
Last November, Olysio was approved by the FDA for treatment of HCV in combination with interferon. Then in May, Olysio received EMA approval for treatment of hep C genotypes 1 and 4. For the first three quarters of this year, Olysio has racked up almost $2 billion in sales, while Sovaldi has generated $8.6 billion during the same period.
The whole point of introducing this class of oral HCV-treatment medications is to provide a convenient way to "cure" HCV, without the adverse effects associated with interferon. At the same time, the oral regimens are easier to complete and sustain than regimens that rely on injectables.
Flexibility increases adherence, but it is quite costly. The cost for patients who were already using Olysio and Sovaldi in combination was $150,000 for a 12-week course. Pricing will continue to be an issue in this treatment category, but as more combination options appear, there is a good chance that more patients will be treated successfully and avoid the long-term consequences of uncured hepatitis C.