MHRA authorises Arrowhead’s plozasiran (Redemplo) for rare lipid disorder
The UK Medicines and Healthcare products Regulatory Agency granted approval for Arrowhead Pharmaceuticals’ plozasiran, marketed as Redemplo, to treat adults with familial chylomicronaemia syndrome (FCS). The decision, issued on 19 October 2026, follows a phase‑3 trial of 75 patients that showed a median triglyceride reduction of about 80% after 10 months, compared with 17% on placebo. The drug is given as a 25 mg sub‑cutaneous injection once every three months and may lower the risk of acute pancreatitis.
Why it matters
The approval adds the first disease‑specific therapy for FCS in the UK, giving Arrowhead a new market opportunity and offering patients a treatment that could markedly reduce triglyceride levels and pancreatitis episodes. The UK market will now have access to Redemplo alongside dietary management.
Key facts
- 1The MHRA granted authorisation for plozasiran on 19 October 2026. openaccessgovernment.org
- 2Plozasiran is administered as a 25 mg sub‑cutaneous injection once every three months. medscape.com
- 3The supporting phase‑3 trial enrolled 75 adults with FCS, with 50 receiving plozasiran and 25 receiving placebo. medscape.com
- 4After 10 months, the median reduction in triglyceride levels was about 80% in the plozasiran group versus 17% in the placebo group. medscape.com
- 5Hyperglycaemia was the most common side effect, affecting more than one in ten patients. openaccessgovernment.org
- 6Fewer acute pancreatitis episodes were recorded among participants receiving plozasiran. openaccessgovernment.org
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.