Amgen's PCSK9 Inhibitor A Step Closer To EU Approval

Amgen (AMGN - Analyst Report) is a step closer to gaining EU approval for its cholesterol management candidate, Repatha (evolocumab) with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of the experimental treatment in certain patients with high cholesterol.

The positive opinion covers the use of Repatha for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet in combination with a statin, or a statin with other lipid-lowering therapies in patients unable to reach LDL-C (bad cholesterol) goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Repatha also received a positive opinion for use in the treatment of adults and adolescents (12 years and above) with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.

The next step in the regulatory process involves the review of the CHMP’s opinion by the European Commission (EC), which has the authority to approve medicines for the EU.

PCSK9 inhibitors work by inhibiting PCSK9, a protein that reduces the liver's ability to remove "bad" cholesterol from the blood. However, Amgen is not the only company working on bringing a PCSK9 inhibitor to market. Sanofi (SNY -Analyst Report) and Regeneron (REGN - Analyst Report) are also seeking EU and U.S. approval for their PCSK9 inhibitor Praluent. While Amgen could well have a head-start in the EU where Sanofi and Regeneron’s regulatory application for Praluent was accepted for review in January, Praluent could gain FDA approval ahead of Repatha given the FDA action date of Jul 24. This is ahead of the FDA action date of Aug 27 for Repatha.

But before that, both Praluent and Repatha will be reviewed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in early June. Investor focus will remain on the outcome of the FDA advisory panel meetings.

Amgen is a Zacks Rank #2 (Buy) stock. A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD - Analyst Report), a Zacks Rank #1 (Strong Buy) company.