Amgen seeks U.S. approval of new cholesterol-fighting drug




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Amgen Inc said Thursday it applied to . health regulators to sell its cholesterol fighter, evolocumab, becoming the first company to seek approval of a medicine a closely watched class of potent heart .

Amgen is racing with Regeneron Inc to bring to market the potentially lucrative aimed at patients unable to tolerate widely used statins, and those who cannot sufficiently lower cholesterol despite of statins, such as Pfizer Inc’s Lipitor, or other medicines.

The injectable work by blocking a naturally occurring protein called PCSK9 prevents the liver removing LDL cholesterol, the “bad” cholesterol, the bloodstream.

In large clinical trials, evolocumab cut LDL levels by more 50 percent even in patients already taking other cholesterol medicines.

Analysts have forecast multibillion-dollar sales for the biotech drugs, if they demonstrate an ability to significantly reduce heart attacks and deaths in larger ongoing trials, as statins have.
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While Amgen was the first to file for . approval of a PCSK9 inhibitor, Regeneron and French partner Sanofi have an ace up their sleeve could enable them to catch up or even reach the market first with their drug, alirocumab.

In late July, the said they paid $67.5 million to acquire a special voucher BioMarin Pharmaceutical Inc could assure alirocumab an expedited six-month . regulatory , rather the 10 months.

Pfizer Inc is also developing a PCSK9 inhibitor, but is behind Amgen and Regeneron.

Amgen is expected submit approval applications for evolocumab to regulators in Europe and other markets in the coming months.

Amgen shares were up 77 cents, or 0.6 percent, at $138.60, while Regeneron shares were off 76 cents, or 0.2 percent, at $349.25 Nasdaq. (Reuters)[eap_ad_3]