Lilly’s Efient tipped for expanded NICE approval
pharmafile | June 20, 2014 | News story | Sales and Marketing | Effient, Efient, FDA, NHS, blood, lilly, longston, thinner
Eli Lilly’s anti-platelet drug Efient has been given the nod by UK healthcare watchdog NICE for more widespread use, pending a final review.
The health technology assessor has issued draft guidance recommending Efient (prasugrel) in combination with aspirin to prevent blood clots for patients who have previously had a heart attack, have unstable angina or are preparing for artery-widening surgery.
In 2009, the drug won NICE approval for high-risk patients who were both undergoing surgery and had a history of heart attack or angina. Now it is likely to expand in use as an anti-clotting agent alone.
Director of the Centre for Health Technology Evaluation at NICE, Professor Carole Longson, confirms: “The draft guidance now recommends prasugrel as an option for more people with acute coronary syndromes than our previous guidance.”
Heralded as a potential market leader on its release, Efient (or Effient as it is known in the US) failed to take off due to concerns over bleeding risks. Upon its US release, it carried a black box warning to this effect, which is thought to have put off some practitioners.
Initial sales in the region were disappointing – it failed to top $4 million in the final quarter of 2009 – and by late 2010, news service FiercePharma had branded it one of ‘pharma’s biggest flops’.
More recently it has rallied, posting global sales of more than $500 million in 2013 – although it has failed to live up to the blockbuster hype of five years ago.
NICE’s latest decision may help Lilly shore up its share of the market with rival product Zontivity (vorapaxar, Merck) winning FDA approval in the US in April and currently under evaluation in Europe.
However, Lilly may not be too concerned about the threat posed by Zontivity. The new drug has safety issues of its own with one analyst at Decision Resources suggesting it has only ‘modest’ market potential.
Efient is also approved for patients with diabetes, and Longson adds that data has shown it is more effective at reducing cardiovascular events after surgery than former dominant treatment Plavix (clopidogrel, Sanofi, now off-patent).
Hugh McCafferty
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