Gilead gets US FDA approval for inflammatory liver disease drug
Adds pricing in paragraph 4, company comments in paragraphs 6-7, details on common symptom in paragraphs 10-12
By Puyaan Singh and Leroy Leo
Aug 14 (Reuters) -The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' GILD.O liver disease treatment, Livdelzi, which it gained through a $4.3 billion buyout of CymaBay Therapeutics earlier this year.
The disease, primary biliary cholangitis (PBC), causes inflammation of the small bile ducts in the liver and can eventually destroy them. It mainly affects women aged 35 to 60.
The American Liver Foundation estimates that about 65 out of every 100,000 women in the U.S. have PBC.
Livdelzi's list price is $12,606 per 30 days of therapy. Rival drug, Iqirvo, from Ipsen IPN.PA costs $11,500 per month.
BMO Capital Markets analyst Evan Seigerman sees $847 million in annual peak sales for Livdelzi, accelerating growth for Gilead's liver drug portfolio, which posted a 17% increase in second-quarter revenue.
Gilead expects the drug to have modest sales in the first couple of quarters, before sales become "much more meaningful in 2025 and beyond", Chief Commercial Officer Johanna Mercier told Reuters.
Mercier said the drug was a "great strategic fit", given the company's experience with liver disease treatments.
The FDA's accelerated approval for Livdelzi is based on a 193-patient study, in which 62% of the participants who received a combination of the drug and ursodeoxycholic acid (UDCA) showed an improvement in biochemical response after one year.
About 40% of PBC patients do not respond to the generic drug UDCA as their first line of treatment, according to a study last year.
Gilead's once-daily pill also showed a statistically significant reduction in itching — a symptom that more than half of the PBC patients experience.
Treatment with Ipsen's Iqirvo has also not shown statistically significant reduction in itching, whereas Intercept Pharmaceuticals' ICPT.MX Ocaliva can worsen itching.
The FDA's accelerated nod to Livdelzi can be converted to a standard approval if it shows improvement in survival or preventing liver function deterioration in a confirmatory study.
Reporting by Puyaan Singh, Christy Santhosh and Leroy Leo in Bengaluru; Editing by Devika Syamnath and Shilpi Majumdar
免責聲明: XM Group提供線上交易平台的登入和執行服務，允許個人查看和/或使用網站所提供的內容，但不進行任何更改或擴展其服務和訪問權限，並受以下條款與條例約束：（i）條款與條例；（ii）風險提示；（iii）完全免責聲明。網站內部所提供的所有資訊，僅限於一般資訊用途。請注意，我們所有的線上交易平台內容並不構成，也不被視為進入金融市場交易的邀約或邀請 。金融市場交易會對您的投資帶來重大風險。
所有缐上交易平台所發佈的資料，僅適用於教育/資訊類用途，不包含也不應被視爲適用於金融、投資稅或交易相關諮詢和建議，或是交易價格紀錄，或是任何金融商品或非應邀途徑的金融相關優惠的交易邀約或邀請。
本網站的所有XM和第三方所提供的内容，包括意見、新聞、研究、分析、價格其他資訊和第三方網站鏈接，皆爲‘按原狀’，並作爲一般市場評論所提供，而非投資建議。請理解和接受，所有被歸類為投資研究範圍的相關内容，並非爲了促進投資研究獨立性，而根據法律要求所編寫，而是被視爲符合營銷傳播相關法律與法規所編寫的内容。請確保您已詳讀並完全理解我們的非獨立投資研究提示和風險提示資訊，相關詳情請點擊 這裡查看。
