Merck прекращает производство и дистрибуцию в США препарата от гепатита С "Victrelis"
Merck & Co. said it will voluntarily discontinue manufacturing and distributing the hepatitis C therapy Victrelis (boceprevir) in the US by December this year. In a letter posted to the FDA's website, the company noted that the decision was based on "scientific advancement, changes in treatment practices, and the consequent reduction in the demand" for the product in the country.
Merck indicated that the therapy, which was approved by the FDA in 2011, will be supplied to wholesalers from existing inventories through the end of this year to ensure that patients currently using the drug will be able to complete up to 48 weeks of treatment. The drugmaker recommended that doctors do not start new patients on the treatment.
The company's decision follows the US approvals of several new hepatitis C treatments, including Gilead Sciences' Sovaldi (sofosbuvir) in December 2013, and more recently Harvoni, which combines Sovaldi with the NS5A inhibitor ledipasvir. AbbVie's all-oral regimen consisting of Viekira (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) was authorised by the agency under the name Viekira Pak last month.
Johnson & Johnson's chief financial officer Dominic Caruso indicated in the wake of the Harvoni approval that his company hopes "to remain competitive in the hepatitis C category" despite lower expected sales from its NS3/4A protease inhibitor Olysio (simeprevir), which was cleared by the FDA in November 2013 and is co-marketed with Medivir. Caruso said at the time that Johnson & Johnson is "committed to hepatitis C," describing it as a "substantial" market. Meanwhile, Bristol-Myers Squibb recently withdrew its FDA application for the NS3/4A protease inhibitor asunaprevir, citing "the rapidly evolving hepatitis C...treatment landscape in the US."
Still, Merck said last week that it plans to expedite the FDA filing for another hepatitis C therapy, combining the NS3/4A protease inhibitor grazoprevir and the NS5A inhibitor elbasvir, to earlier this year than expected following a recent overhaul of its R&D operations.