Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU
Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU
WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA).
美國瓦爾瑟姆市，2024年6月28日 (環球社)——Apellis製藥公司 (納斯達克: APLS) 今天宣佈，歐洲藥物管理局 (EMA) 人用藥品專門委員會 (CHMP) 對眼球內注射的PEG-C3複合物亞型治療周圍萎縮申請採取否定意見。該委員會多名成員不同意這一意見。Apellis計劃申請重新審查，並預計於2024年第四季度得出最終意見。今天的意見是在Ad Hoc專家組會議之後形成的，在該會議上，專家們一致同意GA病變大小是GA試驗的可接受主要結果措施，微視野測定是GA的最佳可用功能測量。
Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion in the fourth quarter of 2024. Today's opinion followed an Ad Hoc Expert Group meeting, in which the experts agreed that size of GA lesion is an acceptable primary outcome measure for a trial in GA and that microperimetry is the best available functional measure in GA.
值得注意的是，CHMP成員對該意見有多次異議投票。Apellis計劃申請重新審查，並預計於2024年第四季度得出最終意見。今天的意見是在Ad Hoc專家組會議之後形成的，在該會議上，專家們一致同意GA病變大小是GA試驗的可接受主要結果措施，微視野測定是GA的最佳可用功能測量。
As previously announced, this review was led by the original rapporteurs following the EMA reset to Day 180 of the initial MAA assessment procedure.
正如《華盛頓郵報》今年早些時候所指出的那樣，數據中心在2022年消費的全國電力總量超過了4％。鑑於人工智能和各種數字創新的爆炸性需求，這並不令人驚訝。然而，這些技術對電網造成了巨大壓力。如前所述，這一審查是由最初MAA評估程序的報告人領導的。我們致力於提供給歐洲對這種導致不可逆視力損失的可怕疾病無法得到治療的GA患者最好的治療方法，我們很高興看到歐洲視網膜社區對PEG-C3複合物亞型治療周圍萎縮的廣泛支持，我們重視及時啓動重新審查進程，以將這種重要的治療方法帶給那些需要的人。"
"We remain steadfast in our commitment to GA patients in Europe who have no treatment for this devastating disease, which leads to irreversible vision loss," said Jeffrey Eisele, Ph.D., chief development officer, Apellis. "It is encouraging to see the broad support for pegcetacoplan within the European retina community, and we are focused on promptly initiating the re-examination to bring this important treatment to those in need."
PEG-T3是一種正處於試驗階段的靶向C3治療方案，旨在調節身體免疫系統的過度激活，該系統是導致許多嚴重疾病發生和發展的原因。SYFOVRE (pegcetacoplan injection) 已獲得美國批准用於治療因年齡相關性黃斑部退化引起的GA。
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3
關於地理萎縮症(GA)
地理萎縮症(GA)是老年性黃斑部病變的高級形式，全球主要致盲原因之一，影響100萬美國人和500萬全球患者。病變的增長破壞視網膜細胞，導致視力障礙。受GA引起的視力喪失，嚴重影響生活質量和獨立性，使日常活動變得困難。平均來說，只需要2.5年，GA病變就會開始影響負責中央視覺的黃斑區。1,2這是一種逐漸發展且不可逆轉的疾病，由病變的增長引起，破壞負責視覺的視網膜細胞。由GA引起的視力障礙嚴重影響獨立性和生活質量，使日常活動變得困難。平均只需要2.5年，GA病變就會開始影響負責中央視覺的黃斑區。3
About Pegcetacoplan for Geographic Atrophy (GA)
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. SYFOVRE (pegcetacoplan injection) is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
關於PEG-C3複合物亞型治療周圍萎縮 (GA) 的信息
PEG-C3複合物亞型治療周圍萎縮是一種正在進行試驗的靶向C3療法，旨在調節身體免疫系統的過度激活，該系統是許多嚴重疾病發生和發展的原因。SYFOVRE (pegcetacoplan injection) 已獲得美國批准用於治療因年齡相關性黃斑部退化引起的GA。本新聞稿中有關未來期望、計劃和前景的聲明，以及與非歷史事實有關的任何其他聲明，均可構成《1995年私人證券訴訟改革法案》中所規定的“前瞻性聲明”。"預計"、"相信"、"持續"、"可能"、"預估"、"期待"、"打算"、"可能"、"計劃"、"潛在"、"預測"、"項目"、"應該"、"目標"、"將"、"會"和類似表達意願的用語，旨在區分前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別用語。實際結果可能因各種重要因素而有所不同，包括PEG-C3複合物亞型對GA是否會獲得外國監管機構的批准，以及是否會按預期時間或根本不會批准，以及Apellis在2024年2月27日提交的《10-K年度報告中》的“風險因素”部分以及Apellis可能在提交給證券交易委員會的其他文件中描述的風險。本新聞稿中包含的任何前瞻性聲明僅於此之日起，Apellis明確放棄更新任何前瞻性聲明有任何義務。
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
關於Apellis
Apellis Pharmaceuticals, Inc.是一家全球性生物製藥公司，融合了勇氣科學和同情心，爲一些患者面臨的最具挑戰性的疾病開發改變生命的療法。我們引進了15年來的第一類新的互補醫學，並已經獲得兩個批准的藥物，針對C3。這些包括全球最主要致盲病因之一的地理性萎縮的第一個療法。我們認爲，我們只是開始解鎖針對C3治療嚴重的視網膜，罕見疾病和神經系統疾病的潛力。http://apellis.com或關注我們的推特和頁面。LinkedIn.
Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether pegcetacoplan will receive approval from foreign regulatory agencies for GA when expected or at all, including the impact on the likelihood and timing of such approvals, and other factors discussed in the "Risk Factors" section of Apellis' Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Media Contact:
Tracy Vineis
media@apellis.com
617.420.4839
Apellis前瞻性聲明
Tracy Vineis
617.420.4839
Meredith Kaya
媒體聯繫人：
Tracy Vineis
media@apellis.com
617.420.4839
Investor Contact:
Meredith Kaya
meredith.kaya@apellis.com
617.599.8178
投資者聯繫人：
Meredith Kaya
meredith.kaya@apellis.com617.599.8178
1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
2Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
3Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
1Rudnicka AR，Jarrar Z，Wormald R等。白種歐洲人口中年齡相關黃斑變性的患病率的年齡和性別變異：一項Meta分析。Ophthalmology 2012;119:571-580。
2Wong WL，Su X，Li X等。全球年齡相關黃斑變性的患病率及2020年和2040年的疾病負擔預測：一項系統評價和Meta分析。Lancet Glob Health 2014;2:e106-116。
3Lindblad AS等，以及AREDS研究小組。Arch Ophthalmol。2009年;127（9）：1168-1174。
譯文內容由第三人軟體翻譯。