Date: 2015-07-08
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the Japanese Atherosclerosis Society (JAS) Annual Scientific Meeting
Company: Sanofi (France) Regeneron Pharmaceuticals (USA - NY)
Product: Praluent® (alirocumab)
Action
mechanism:
- monoclonal antibody/RNAi/PCSK9 inhibitor. Alirocumab (SAR236553 / REGN727) is a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in clinical development. By inhibiting PCSK9, a determinant of circulating LDL-cholesterol levels in the blood, REGN727 increases the number of free LDL receptors which can bind to circulating LDL and clear it from the bloodstream. REGN727 was created using Regeneron's pioneering VelocImmune® technology and is being developed by Regeneron in collaboration with Sanofi.
Disease: patients with hypercholesterolemia at high cardiovascular (CV) risk, heterozygous familial hypercholesterolemia (HeFH),
Therapeutic
area: Cardiovascular diseases - Genetic diseases - Rare diseases
Country: Japan
Trial
details: ODYSSEY JAPAN involved 216 Japanese patients with hypercholesterolemia at high cardiovascular (CV) risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
Latest
news:
- • On July 8, 2015, Regeneron Pharmaceuticals and Sanofi announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent® (alirocumab) Injection met its primary endpoint. These primary results from ongoing 52 week ODYSSEY JAPAN trial were presented at the Japanese Atherosclerosis Society (JAS) Annual Scientific Meeting, in Sendai. At week 24, patients in the Praluent group experienced an average 64 percent greater reduction from baseline in their bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C), when added to current standard of care including statins, compared to standard of care alone (p less than 0.0001). Patients were started on the lower dose of 75 mg, with the option to adjust their dose to 150 mg if they had not achieved their LDL-C goal (as defined by the Japan Atherosclerosis Society guidelines) at week 8. At week 24, 97 percent of patients in the Praluent group reached their LDL-C treatment goal, compared to 10 percent for placebo (p less than 0.0001). Ninety-nine percent of patients treated with Praluent remained on the lower dose; two patients required adjustment to the higher dose.
ODYSSEY JAPAN evaluated Praluent (n=144) compared to placebo (n=72), both on top of standard care, in Japanese patients with hypercholesterolemia, with either HeFH or at high CV risk, and who could not reach their LDL-C treatment goal as defined by the JAS guidelines despite lipid-lowering treatments that included statins. The mean LDL-C value at baseline was 141.2 mg/dL. Patients were initially randomized to receive either Praluent 75 mg every two weeks administered as a single 1 milliliter (mL) injection, or placebo. Patients in both groups received statins, with or without other lipid-lowering therapies.
- Ninety-nine percent of patients who received Praluent at week 8 remained on the initial 75 mg dose, while one percent of patients had their dose adjusted to receive 150 mg every two weeks, also as a single 1 mL injection. The most common adverse events (occurring in at least 5 percent of patients in the Praluent group) were nasopharyngitis, injection site reaction, and back pain.
Is
general: Yes
