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FDA approves Olysio/Sovaldi combination in hep C

Janssen drug recommended for use along with Gilead’s blockbuster
Janssen Olysio simeprevir

The US FDA has approved a combination of two fast-growing new hepatitis C drugs: Janssen's Olysio and Gilead Sciences' Sovaldi.

The decision means that oral NS3/4A protease inhibitor Olysio (simeprevir) and Sovaldi (sofosbuvir), an HCV nucleotide analog NS5B polymerase inhibitor can be used as part of the same regimen in people with hepatitis C genotype 1.

Both drugs are part of a wave of new hepatitis C treatments that have achieved remarkable sales since launching in the past couple of years.

Olysio, which is also known as Sovriad in some regions, recorded revenues of $1.69bn for the first nine months of 2014 after launching at the end of 2013.

However, these figures – like most in pharma history – have been blown out the water by Sovaldi, which made $8.5bn for Gilead in the first nine months of 2014.


Gilead Sciences' Sovaldi has had the most successful pharma launch in history

The approval of the Olysio/Sovaldi combination is crucial for Janssen as it looks to keep pace with Gilead in hepatitis C.

The main competition for the regimen is Gilead's Harvoni, a combination of Sovaldi and the NS5A inhibitor ledipasvir that was approved in the US as a single tablet last month.

Once it gained FDA approval Harvoni became the first all-oral, interferon and ribavirin-free option available in the US.

Now patients have a second all-oral, interferon and ribavirin-free option in the form of Olysio and Sovaldi and Janssen will be keen to make the most of both drugs already significant presence in the market.

Gaston Picchio, hepatitis disease area leader at Janssen research and development, said: “The availability of multiple treatment options is important to help offer an opportunity for cure and we believe Olysio will play a meaningful role in this respect."

10th November 2014

From: Sales



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