Crestor approval lifts AstraZeneca
pharmafile | October 21, 2003 | News story | |Â Â Â
AstraZeneca has been boosted by the first regulatory approval in the Netherlands of Crestor, its 'superstatin' cholesterol treatment.
The drug is now expected to gain approval in 16 other European countries in the first half of 2003, to be followed by clearance in Japan and the all-important US market by the end of next year.
Crestor is the Anglo-Swedish company's biggest new hope for a blockbuster drug, and now seems to have distanced itself from safety concerns that have delayed its approval in the US.
Hamish Cameron, Vice President, Cardiovascular, said: "Crestor is a new statin with a best in class efficacy profile allowing more people to reach their LDL targets with their starting dose. The safety profile of Crestor is very comparable to other marketed statins."
He reiterated the company's view that the halting of high dose trials because of safety concerns earlier this year was irrelevant to the 10 to 40mg dose range of the drug.
Mr Cameron indicated the company would underline to prescribers evidence that shows many high risk patients fail to reach their LDL ('bad' cholesterol) reduction targets on existing statins.
"Approximately half of the people on cholesterol lowering therapy are still not reaching their cholesterol targets and are at risk of heart attacks and strokes. With the efficacy wee seen in clinical studies, Crestor could make a real difference to those patients' lives."
AstraZeneca is already following in the footsteps of Pfizer and Merck (marketer of Zocor) by conducting a large scale trial to prove its product can not only lower cholesterol but also reduce deaths due to cardiovascular disease.
Existing studies have already boosted the image of the individual products and the whole statin class as wonder drugs, with many more likely but as yet unproven medical applications.
The approval has been marred by news that Crestor and other superstatins may be referred to NICE, as UK Government concerns grow about rising prescribing costs.
Heart Czar Roger Boyle told Pharmafocus the Department of Health was considering a NICE review of Crestor cost-effectiveness compared to existing treatments, including Zocor, which is due to lose its patent early next year.
The global market for statins is estimated to be worth more than $18 billion a year, and growing at a rate of about 20% annually.
The company received further good news in the shape of a US recommendation to fast-track the approval of Iressa for third line treatment of non-small cell lung cancer.
Other data presented at the company's annual business review included encouraging phase III results from Exanta, a post-surgery anti-blood clotting treatment.
