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Merck & Co gets EU green light for hep C drug Zepatier

Will enter a market currently dominated by Gilead's Harvoni and Sovaldi

Merck & Co HQ 

Merck & Co can now sell its new hepatitis C virus (HCV) treatment Zepatier on both sides of the Atlantic following approval by the European Commission.

Zepatier (elbasvir/grazoprevir) has been approved for use with or without ribavirin as a treatment for chronic HCV in adults with genotype 1 and 4 infections, the same indication cleared by the US FDA in January.

The new drug launches into a market currently dominated by Gilead Sciences with its Harvoni (sofosbuvir/ledipasvir) combination and single-agent product Sovaldi (sofosbuvir), with AbbVie also pressing for market share with its rival therapy Viekirax/Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir).

Merck (known as MSD outside the US) has entered the market at a discount to its rivals in a bid to quickly claim market share from the more established drugs.

Merck said in its second-quarter results statement that Zepatier sales have been "ramping up nicely" since its launch in the US earlier this year thanks to swift inclusion in Medicare Part D and other payor formularies. The company reported sales of $112m for the drug in the second quarter, its first full three-month period on sale.

Effective in drug abusers with HCV

Meanwhile, Zepatier has been shown to be a safe and effective therapy for people who inject drugs, a group disproportionately affected by HCV.

The results of the C-EDGE CO-STAR trial are important as they show that people addicted to illicit drugs can benefit from antiviral treatment for HCV, even if they continue to be active users, according to Merck.

According to the World Health Organization (WHO), there are around 13 million people who inject drugs, with two thirds infected with HCV. Moreover, there are around 2.2 million people worldwide co-infected with HCV and HIV, and more than half are in illicit injectable drug users.

C-EDGE CO-STAR is the first phase III trial examining directly-acting antivirals against HCV in patients who inject drugs but who are also on opioid agonist therapy (OAT) to try to help them kick the habit. 

The results - which have just been published online on the Annals of Internal Medicine website - reveal that 92% of those treated with Zepatier for 12 weeks saw the virus cleared from their bodies. Critically, the patients were able to adhere to treatment and drug use at baseline and during treatment did not affect cure rates or compliance.

Article by
Phil Taylor

9th August 2016

From: Regulatory

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