NICE approves Effient for broader use
- NICE has approved expanded use of Effient (prasugrel), an Eli Lilly product, beyond “high risk” patients---defined in 2009 as patients who both have a history of heart attack and are also undergoing surgery.
- NICE has now broadened its recommendation for Effient to include more people with acute coronary syndromes (ACSs).
- In the US, Effient has a black box warning associated with bleeding risk, and overall global sales of Effient have been disappointing in the last five years. However, sales have ticked up recently.
The new guidelines recommend using Effient in combination with aspirin to prevent blood clots in individuals who have experienced heart attack, have unstable angina or are preparing to undergo surgery to widen their arteries. Effient is also approved for use in individuals with diabetes.
There is a rival product on the competitive landscape---Merck’s Zontivity (vorapaxar), which was approved by FDA in April and is currently being reviewed in the EU. Zontivity also has some safety issues, but in reality, although clopidogrel still plays a role in the antithrombotics market, there is demand for additional anti-clotting agents, with acceptable levels of efficacy and safety, to treat ACS.
- pharmafile.com Lilly’s Effient tipped for expanded NICE approval