Merck's hep C treatment loses FDA breakthrough status
- Less than two years ago, treating hepatitis C was still considered an "unmet medical need," but with the approvals of Gilead's Sovaldi and Harvoni, as well as AbbVie's Viekira Pak, the FDA no longer categorizes a new hep C treatment as a "breakthrough."
- Merck has been developing a hepatitis C med with the goal of seeking FDA approval as a breakthrough therapy. The combination therapy is comprised of a protease inhibitor (MK-5172) and an NS5A inhibitor (MK-8742).
- Mid-stage trial data on the combo treatment showed a 98% cure rate in patients with genotpye 1 of hepatitis C. Genotype 1 is considered the hardest variant to cure.
Being third to market with a new hepatitis C treatment is challenging on a number of fronts. First, there is the FDA review issue. Given the fact that breakthrough status has been rescinded, Merck's therapy will most likely undergo the standard 10-month review process.
In addition, the competitive landscape for hepatitis C treatments is immensely challenging as payers demand large discounts in exchange for market share. The latest figures show that Gilead has discounted its prices for its treatments an average of 46%.
Merck's strategy is to move forward with clinical trial testing, and also to explore triple-combination therapies with other drugs, such as grazoprevir, to provide additional treatment options. The company predicts that eventually it will garner up to one-fifth of the hepatitis C market, with billions of dollars per year in sales.