Hemlibra, a new drug for heavy hemophilia, suffered five deaths!
April 2, 2018 Source: CPhI Pharma Online Author: Knowing and Doing
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Clarivate Analytics’s 2022 sales of Roche’s hemophilia drug Hemlibra exceeded $4 billion in 2022, but the American Hemophilia Alliance blew out deaths in 2018 after Hemlibra treatment in hemophilia patients. Roche is undoubtedly a bad news. In order not to affect Hemlibra's sales and hemophilia market share, Roche took the initiative to report details of five patient deaths since Hemlibra's clinical practice, and said in multiple media that patient deaths have nothing to do with Hemlibra.
Recently, foreign media repeatedly reported a news about "the death of five patients associated with Roche's new hemophilia drug Hemlibra", which undoubtedly cast a shadow over the sales of the heavy new drug Hemlibra, and also caused Roche's share price to drop by 1.4. %.
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March 2018 is a period of ups and downs for the hemophilia market and Roche. First, Clarivate Analytics predicts the next 12 new drugs, including Roche's bispecific for the treatment of hemophilia A. The antibody Hemlibra topped the list with sales of $4 billion in 2022; however, not long after, the American Hemophilia Federation (NHA) issued a statement saying that two patients died after using Hemlibra this year, which is undoubtedly a Very bad news.
Immediately after Roche's Genentech responded to the NHA, it confirmed on March 27, 2018 that Hemlibra had entered the clinic with a total of five patient deaths and said that it would receive any Hemlibra medication and safety telephone consultation. According to the NHA, "Genentech has very little information about recent patient deaths; however, Genentech can confirm that patients did receive Hemlibra as a sympathetic medication and acquired the drug through an expanded protocol." Also sent to Endpoints News at Roche. In a statement, Roche acknowledged that three patients died of Hemlibra treatment through a "sympathetic medication"; one patient received the drug through an extended medication agreement; and one patient died in a HAVEN1 phase III clinical study. in.
Roche made the following timeline for the current five deaths and explained:
1) In 2016, an adult patient who was treated with Hemlibra by "sympathetic medication" was killed;
2) In 2017, an adult patient who participated in the HAVEN1 Phase III clinical study died, and an adult patient who received Hemlibra treatment through "sympathetic medication" died;
3) In 2018, we (Roche) only recently learned that two patients treated with Hemlibra died. Again, according to the evaluation of the doctors of the two patients, the death of two patients was not associated with Hemlibra.
The following five cases of death using Hemlibra are described as follows: 12016 patient death was due to "intracranial hemorrhage and widespread bacterial infection", the doctor concluded that it was not related to Hemlibra; 2 the first death patient in 2017 before receiving Hemlibra treatment There are symptoms of intracranial hemorrhage, also considered to be unrelated to Hemlibra; the second death in 32017 occurred in the HAVEN1 III clinical trial due to rectal bleeding, not Hemlibra; the first death in 42018 was in the past Suffering from "abdominal pseudotumor" and dying from the corresponding complications; the second patient in 52018 died after major vascular surgery.
Two recent patient deaths in 2018 are still under investigation and evaluation. Roche is conducting a "conscious evaluation and report writing". A Roche spokesperson said, "We understand the urgency of safety incident investigation and evaluation, based on careful assessment. Accurate Hemlibra safety information has the highest priority. However, Jefferies analyst David Steinberg said in a report on the Hemlibra incident that scholars have not fully understood the mechanism behind Hemlibra as a new type of hemophilia therapy. Hemlibra is not well controlled like Advate and may have potentially unknown effects on non-inhibitor patients.
Although Clarivate Analytics predicts that Hemlibra's sales in 2008 will be as high as $4 billion, Hemlibra's security issues will undoubtedly prevent Roche from meeting such expectations. If this survey and assessment does not have a favorable outcome for Roche, then the potential market share that would otherwise belong to Hemlibra will undoubtedly fall to its competitor Shire's Feiba and Advate, Shire will face an important turning point, while Takeda Whether or not to acquire Shire will also become confusing. However, the author speculates that Roche will safely survive this difficult time, on the one hand because Hemlibra has received FDA orphan drug identification, priority evaluation and breakthrough therapy identification, which is recognized and favored by the FDA; The FDA approved the side effects mentioned in the Hemlibra market: injection site reaction, headache, joint pain, and little connection with the death of the above 5 patients.
Reference source:
1. UPDATED: Hemophilia groups warned of 5 deaths among patients taking Roche's big new blockbuster Hemlibra;
2. Under fire for 5 deaths of patients taking Hemlibra, Roche spills details;
3. As hemophilia market heats up, Roche confirms 5 Hemlibra patient deaths.
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