There were no big surprises for Gilead's ($GILD) $11 billion hepatitis C drug sofosbuvir at today's FDA panel review. The therapy, which promises to help create an entirely new standard of care for the millions of people afflicted with the virus, won a clear endorsement from agency experts. And now it's likely headed for a near-term approval as the FDA formally considers the application.
The panel voted unanimously that the drug and various combinations should be approved for all four basic genotypes. Sofosbuvir was endorsed in combination with ribavirin for genotypes 2 and 3, and in genotypes 1 and 4 in combination with ribavirin as well as in combination with interferon for treatment-naive patients.
The agency already signaled its views in an internal review released earlier this week which heralded the therapy as the first interferon-free drug that clearly demonstrated its efficacy and safety among important groups of hep C patients.
The likely quick approval of sofosbuvir will be followed up with new combination drugs that can effectively quell the virus quickly. The aim here is to rid the world of interferon injections, which have a harsh impact on patients. And AbbVie ($ABBV), Bristol-Myers Squibb ($BMY) and others are hustling along new therapies that will soon offer a variety of choices for physicians and their patients.
Analysts project that sofosbuvir, though, will continue to play a major role in fighting hep C, with annual peak sales estimates now hovering around $7 billion.
The FDA internal review concluded that "the currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C. In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population.
"In the HCV GT 1 and 4 populations, sofosbuvir in combination with pegylated interferon and ribavirin provides increased efficacy and shorter treatment duration compared with currently approved regimens. The shorter 12 week duration translates into a better tolerated side effect profile with observed treatment discontinuations due to AEs of less than 2%. The available data are believed to be insufficient to make definite dosing recommendations for patients with GT 5 or 6."