Merck & Co hit a setback in its hepatitis C ambitions with the decision by the US FDA to rescind the ‘breakthrough’ therapy status for a new oral drug.
The company said in its financial statement for 2014 that its combination of grazoprevir and elbasvir no longer qualifies for the designation due to availability of recently approved hepatitis C medicines.
The FDA reserves its breakthrough status for medicines that demonstrate substantial improvement over available therapies in early clinical trials and is intended to speed up the development and review process for new drugs.
By having the status rescinded for grazoprevir/elbasvir rescinded Merck misses out on several benefits during the review process, including intensive guidance on an efficient drug development programme, organisational commitment involving senior managers and all the features of the FDA’s ‘fast track’ programme.
Merck said it “expects to discuss this matter with the FDA” and still intends to go through with the marketing application for grazoprevir/elbasvir.
The hepatitis C market has seen a number of major new oral treatments launched in the past couple of years that offer 90%+ cure rates and more convenient regimens than previous therapies.
These have been led by Gilead Sciences’ Sovaldi (sofosbuvir), which had sales of more than $10bn for 2014 after being launched at the end of 2013.
The drug has since been joined by Gilead’s Harvoni, which combines Sovaldi with ledipasvir and has been a major success in its own right with sales of $2bn in 2014 after launching towards the end of the year.
Other new hepatitis C treatments include AbbVie’s Viekira Pak and Janssen’s Olysio (simeprevir).