Shares of Amgen, Inc. [NASDAQ:AMGN] surged 1.55% to close at $157.96 per share on Thursday after the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), expert advisory panel of the U.S. Food and Drug Administration (FDA), voted 11 to 4 to recommend the approval of Repatha (evolocumab) for the treatments of patients with familial hypercholesterolemia (FH), an inherited condition that causes high levels of low density lipoprotein (LDL) cholesterol levels beginning at birth, and heart attacks at an early age. 

The committee also voted 15-0 in favor of approval for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare genetic cholesterol disorder. The Biologics License Application (BLA) for Repatha was accepted by the FDA with a target action date of August 27, 2015.

Repatha and other PCSK9 inhibitor drugs are monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. FH is an inherited condition caused by genetic mutations and is characterized by raised serum LDL cholesterol levels, which result in excess deposition of cholesterol in tissues, leading to accelerated atherosclerosis and increased risk of premature coronary heart disease.

The common form of FH, which causes high LDL levels, is heterozygous FH (HeFH), meaning one FH gene and one normal gene. On the other hand, HoFH is very rare and is characterized by extremely high levels of LDL cholesterol. For those with HoFH, heart attacks and death often occur before age 30. It is estimated that less than one percent of people with HeFH and HoFH in the U.S. are diagnosed.

On Wednesday, the EMDAC voted 13 to 3 to recommend the approval of Praluent (alirocumab), a PCSK9 inhibitor drug developed by Sanofi [NYSE:SNY] and Regeneron Pharmaceuticals [NASDAQ:REGN].

Sanofi and Regeneron are seeking FDA approval of Praluent for treatment of patients with hypercholesterolemia whose LDL levels are insufficiently controlled by generic statins and for patients who can't handle statin therapy. The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015.

Both Repatha and Praluent are injectable. Repatha is administered at a dose of 140 mg every 2 weeks, or 420 mg once a month. Praluent is administrated at a dose of 75 mg every week, where low LDL-C levels are likely to be of less concern, and then move up to 150 mg when necessary. 

In January, Pfizer [NYSE:PFE] said they are also developing a PCSK9 inhibitor oral pill and vaccine, bococizumab [RN 316], which now is in Phase 3. According to estimates compiled by analysts, the PCSK9 inhibitors have the potential to generate annual sales of as much as $3 billion.

Two high-level, non-PCSK9, LDL cholesterol lowering drugs, have already been approved by the FDA. In January 2014, the FDA approved Kynamro (mipomersen sodium) as an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people to treat HoFH. Kynamro, an injection given once a week, is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis which is developed and commercialized by Isis Pharmaceuticals [NASDAQ:ISIS] and Genzyme, a Sanofi company. 

In December 2012, the FDA approved Juxtapid (lomitapide), developed and commercialized by Aegerion Pharmaceuticals [NASDAQ:AEGR]. Juxtapid, a microsomal triglyceride transfer protein (MTP) inhibitor, is intended for use in combination with a low fat diet and other lipid-lowering treatments.

In the first-quarter of 2015, Amgen reported revenues of $5.03 billion, up 11.3% year-on-year, and adjusted EPS of $2.48, a 32.6% increase from the first-quarter of 2014. The results exceeded the consensus estimates from Thomson Reuters for EPS of $2.10 on revenues of $4.91 billion.

Looking forward for the full year 2015, Amgen raised the low end of its revenue estimate by $100 million to a new range of $20.9 billion to $21.3 billion. The top end of the range was unchanged. The adjusted EPS range rose from $9.05 to $9.40 to a new range of $9.35 to $9.65. Full-year analyst estimates called for EPS of $9.32 and revenues of $20.98 billion.

From our technical viewpoint, AMGN has been moving in a pseudo symmetrical triangle, a chart pattern composed of two symmetrical triangles which overlap each other, since October 2014 as the market can’t decide whether AMGN will move up or down. The trading range has been narrowed from between $172 and $146, to the range between $166 and $151. The stock could be in this trading range until Repatha gets final FDA approval. The direction of the stock movement may depend upon the indications and labeling assigned by the FDA.

The 12-month target price for AMGN on Yahoo Finance is $179.47 per share. Amgen will report its second quarter 2015 earnings on July 27-31. Analysts are expecting earnings of $2.41 per share, up 1.7%, on revenue of $5.31 billion, up 2.5%.

Disclosure: No position in AMGN, long position REGN. No positions in any other companies mentioned. No Recommendations.