Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Last week, Amgen (AMGN) announced that results from two phase III studies on evolocumab (AMG 145), RUTHERFORD-2 and TESLA, were published in The Lancet. Evolocumab is being developed for reducing low-density lipoprotein cholesterol (LDL-C) in patients suffering from different types of familial hypercholesterolemia (FH).
Evolocumab works by inhibiting PCSK9, a protein that lowers the liver's ability to remove “bad" cholesterol from the blood. While the RUTHERFORD-2 study evaluated evolocumab in patients suffering from heterozygous FH, the TESLA study evaluated the candidate in patients suffering from homozygous FH. Results from both the studies showed that evolocumab helped in a statistically significant reduction in LDL-C as compared to placebo.
Evolocumab enjoys orphan drug designation for the homozygous FH indication in the U.S. Last month, the company submitted regulatory application for evolocumab in the EU for the treatment of high cholesterol (read more: Amgen Seeks EU Approval for PCSK9 Inhibitor Evolocumab).
The candidate is also under review in the U.S. for the treatment of high cholesterol (read more: Amgen Submits Regulatory Application for PCSK9 Inhibitor).
Sanofi/Regeneron’s (SNY/REGN) alirocumab is another interesting PSCK9 inhibitor, currently in phase III development.
Amgen has progressed well with its pipeline in the recent past. Alongside, the company has several regulatory decisions pending. We expect investor focus to remain on Amgen’s pipeline going forward.
Amgen holds a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Medivation, Inc. (MDVN) with a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment