Novartis said on Wednesday that FDA has approved its SiRNA Leqvio (Inclisiran) that target PCSK9 as an additional therapy to help reduce the level of cholesterol of certain high -risk adults. The drug will be available in early January 2022. It is suitable for patients with hyperchozozozozohia family (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD) patients who need to reduce LDL cholesterol or clinical atheroscopy. Combined.
<!-AFP Control Code/Caption.
Norhua CEO Vas Narasimhan commented: “Leqvio is a revolutionary therapy. It is the first approved SIRNA -based therapy to reduce low -density lipoprotein cholesterol.
After being rejected last year:
About a year ago, the US Food and Drug Administration issued a complete response letter, rejecting the LEQVIO listing application, because the third -party production facilities had “unsolved” problems. Novartis re -submitted LEQVIO’s application this summer. The company stated that in the re -submitted application, it listed its factory in Austria as the manufacture location of the final finished product.
<!-2664: Cardiovascular terminal page
FDA’s decision is based on the results of the Orion clinical development plan, including the III phase Orion-9, Orion-10 and Orion-11 studies. Compared with placebo, Leqvio provides up to 52% of “effective and persistent” low density fats The protein cholesterol is reduced, although all patients are treated with the maximum tolerance of his tolerance. The drug also has the safety of the placebo. The most common side effects are mild to moderate injection sites reaction, joint pain, urinary tract infections, diarrhea, chest cold, legs or arms pain, and shortness of breath.
LEQVIO is administered through the subcutaneous injection, and the second administration is taken three months later. After that, it will continue to be treated twice a year. The European Drug Administration authorized it in December last year. At the same time, the impact of Leqvio on cardiovascular ending is currently studying.
The Swiss pharmaceutical dealer acquired the Leqvio of The Medicines Company for $ 9.7 billion in January 2020.