Effient approved in US
pharmafile | July 17, 2009 | News story | Research and Development, Sales and Marketing | Daiichi Sankyo, Effient, US, lilly
Lilly and Daaichi-Sankyo have gained US approval of their new blood clotting treatment Effient, but hopes of strong sales are tempered by the safety warning it must carry.
The drug is a major product for both companies, and will now challenge Plavix, one of the biggest selling drugs in the world.
The final FDA approval of Effient marks the end of a year-long wait for the drug to be cleared, and is welcome news after doubts about uncontrolled bleeding in some patients looked set to scupper its chances.
But in February this year an FDA panel recommended Effient (prasugrel), deciding that its greater success in preventing blood clots than Plavix balanced out the higher risk of patients developing dangerous bleeding.
The drug has been approved for use in preventing blood clots in patients with acute coronary syndromes (ACS) who have undergone percutaneous coronary intervention (PCI).
Data suggests Effient reduces the risk of cardiovascular death, heart attack or stroke in ACS PCI patients by 19% when compared to Plavix.
Like Plavix, it can be used in conjunction with aspirin to prevent further heart attacks and strokes. Studies have shown Effient can reduce the risk of recurrence by 35% versus Plavix in trials.
However the FDA has insisted that Effient must carry a black box warning of the increased risk of potentially fatal bleeding, which is likely to deter some doctors and patients from using it.
Plavix does not carry the same strong warning, and Lilly and Daaichi Sankyo are hoping Effient's greater potency in preventing clots will persuade doctors to prescribe it.
Analysts had originally predicted the drug to reach peak annual sales of $3 billion, but many have now tempered their forecasts, with more modest sales of around $1.5 billion forecast.
Plavix is licensed for use in a wide range of other indications, and Lilly and Daiichi-Sankyo will hope that Effient can gain additional indications quickly.
Nevertheless, Effient is not expected to overhaul Plavix, as the established drug has a wealth of data behind it, and is familiar to doctors. Generic versions of Plavix (clopidogrel) are expected to hit the US market by 2011, which will represent a further challenge for Effient in gaining market share.
The co-marketers will launch Effient in the US in the coming weeks, and is likely to be priced as more expensive than Plavix.
Effient is already approved in Europe earlier this year (and spelt as Efient with just one 'f' in Europe), and was launched in the UK in April.
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April 09, 2009
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