FDA approves alirocumab for lowering of LDL in certain patients

The FDA and Sanofi/Regeneron announced that the agency has approved alirocumab, a PCSK9 inhibitor, for lowering of LDL in addition to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia or those with clinical atherosclerotic CVD.

Alirocumab (Praluent, Sanofi/Regeneron) is an antibody targeting PCSK9, a protein that reduces the number of receptors on the liver that remove LDL from the blood, according to an FDA press release. Blocking PCSK9 enables more receptors to rid LDL from the blood and lower LDL levels, the agency stated.

“Praluent provides another treatment option for patients with HeFH or with known [CVD] who have not been able to lower their LDL enough on statins,” John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said in the release. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of [CVD].”

According to the release, approval was based on results from five placebo-controlled trials including a total of 2,476 patients treated with alirocumab. Those assigned alirocumab had a mean LDL reduction of 36% to 59% compared with those assigned placebo, the agency stated.

Sanofi and Regeneron also announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for the marketing authorization of alirocumab, recommending approval for use in certain adult patients with hypercholesterolemia, according to a press release.

Another PCSK9 inhibitor, evolocumab (Repatha, Amgen), received European Commission approval earlier this week for the reduction of LDL in adults with primary hypercholesterolemia or mixed dyslipidemia, either alone or in combination with statins and/or other lipid-lowering therapies; and for the treatment of patients aged 12 years or older with homozygous familial hypercholesterolemia, in combination with other lipid-lowering agents.

The FDA has a target action date of August 27, 2015, under the Prescription Drug User Fee Act for review of evolocumab.

Source: www.healio.com