Amgen’s First-in-Class Cholesterol Drug Nears EU Approval

California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday.

The agency’s Committee for Medicinal Products for Human Use rubber-stamped Repatha (evolocumab) as an adjunct to diet and in combination with a statin or other cholesterol-lowering drug for adults with primary hypercholesterolemia or mixed dyslipidemia who weren’t successfully treated with statins or can’t tolerate them. The panel also recommended approval for adolescents and adults ages 12 and older who have two genes for familial hypercholesterolemia.

Repatha belongs to a new class of cholesterol-lowering therapies called PCSK9 inhibitors, which block a protein that reduces the liver’s ability to remove low-density lipoprotein — or bad cholesterol — from the blood.

It could take several months to get a final decision, says ISI Evercore analyst Mark Schoenebaum. Once that happens, he expects lengthy country-by-country negotiations before prices are determined.

While Repatha has a clear shot at being first to market in the EU, the monoclonal antibody faces likely competition in the U.S. The FDA’s review deadline for the therapy is in late August, close to that of Sanofi and Regeneron’s PCSK9 inhibitor Praluent.

Amgen tried to block Praluent (alirocumab) last fall, claiming patent infringement and complaining that the priority review voucher the companies purchased from BioMarin Pharmaceuticals would grant them a shorter review period.

The drugmaker declined to comment on the status of the lawsuit.

Should Repatha see U.S. approval, Schoenebaum estimates its wholesale acquisition price will be at least $10,000 per year.

Also during the meeting, Johnson & Johnson subsidiary Janssen won another first, picking up another indication for its Imbruvica (ibrutinib), this time for Waldenstrom’s macroglobulinemia, a rare blood cancer that has no approved treatments in Europe.

CHMP also issued positive recommendations for two PD-1 inhibitors: Merck’s Keytruda (pembrolizumab) for adults with advanced melanoma that can’t be surgically removed and Bristol-Myers Squibb’s Opdivo (nivolumab) for adults with squamous non-small cell lung cancer that hasn’t responded to chemotherapy.

The committee rounded out the day with a positive recommendation for United Therapeutics’ Unituxin (dinutuximab) for high-risk neuroblastoma in young children who have responded to chemotherapy, followed by myeloablative therapy and autologous stem-cell transplantation.

The committee’s recommendations will be forwarded to the European Commission, which will make a final decision. — Lena Freund