EVOLOCUMAB APPROVED IN EUROPE

BRUSSELS, BELGIUM — Evolocumab (Repatha, Amgen), one of the so-called PCSK9 inhibitors, is the first agent approved in Europe for the treatment of patients with elevated cholesterol levels.

The European Commission announced the approval of evolocumab today following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last month.

With today's approval, evolocumab is indicated for the treatment of adults with primary hypercholesterolemia, such as heterozygous familial hypercholesterolemia (HeFH) and mixed dyslipidemia. In this setting, the drug, which is given as an injection every 2 weeks or once monthly, is approved for patients currently taking a maximally tolerated statin or other lipid-lowering therapies but unable to achieve sufficient LDL lowering or get to treatment goals.

Evolocumab also received an indication for use in patients unable to tolerate statin therapy and for use in whom a statin is contraindicated. Importantly, evolocumab is also approved for use in combination with statins and other lipid-lowering therapies in adults and adolescents (>12 years old) with homozygous FH (HoFH).

Last month, the EMA said the positive review of data by CHMP is based on the efficacy of evolocumab for lowering LDL-cholesterol in nine studies of patients with hypercholesterolemia/mixed dyslipidemia and two studies of patients with HoFH. Studied in more than 6000 patients followed for at least 6 months and in more than 1100 patients followed for over 2 years, the EMA said they believe the PCSK9 inhibitor is safe.

Evolocumab is available as a subcutaneous injection. The drug is prescribed in two clinically equivalent doses: 140 mg every 2 weeks or 420 mg once a month. For adults or adolescents with HoFH, the initial recommended dose is 420 mg once a month. If an adequate LDL-lowering response is not achieved after 12 weeks in these patients, physicians have the option of increasing the dose to 420 mg every 2 weeks.

The European approval of evolocumab comes just days before a decision is expected from the US Food and Drug Administration (FDA) on alirocumab (Praluent, Sanofi/Regeneron Pharmaceuticals), another PCSK9 inhibitor. Widely expected to be approved by the FDA on July 24, alirocumab received a positive review from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) in early June. As reported by heartwire for Medscape, Sanofi/Regeneron purchased a priority-review voucher for $67.5 million from another drug company in order to shorten the FDA review process for alirocumab.

Evolocumab also received a thumbs-up from EMDAC last month, although a decision on its approval is not expected until late August.