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    Home > Active Ingredient News > Drugs Articles > This $245 million priority review voucher is going to be wasted by Sanofi

    This $245 million priority review voucher is going to be wasted by Sanofi

    • Last Update: 2016-05-26
    • Source: Internet
    • Author: User
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    Source: medicine magic cube data 2016-05-25 also need to know that team jumping not only requires an additional $2.7 million tip, but also no matter what the review result is, the priority review coupon will not be returned once used Sanofi submitted to the FDA on December 23 last year an application for marketing the fixed dose compound of iglarlixi (insulin glargine 100u / ml + ricilar), which is injected once a day for blood glucose control in adult type 2 diabetes patients Sanofi submitted its application with a $245 million priority review voucher from retrophin FDA announced on February 22, 2016 that it accepted the application Sanofi obtained the priority review qualification as expected, and paid an additional 2.7 million urgent fee However, according to the pre meeting documents of the Advisory Committee released on May 23, FDA reviewers questioned the clinical benefits and dosage of iglarlixi On the one hand, they believed that this dosage design might lead to insufficient intake of ricilar for some patients, on the other hand, they believed that the design of the injection pen might lead to incorrect dosage The reviewers also pointed out that the previous clinical study design may be flawed, which does not fully prove that iglarlixi has better clinical benefits than Lantus, because the trial did not compare the treatment effect under the optimal dose of iglarlixi and Lantus FDA reviewers commented that "due to the insufficient dose of Lantus received by some patients, there will be bias in the analysis of clinical trial results, which will be beneficial to compound drugs Using such a study result as supporting evidence that the efficacy of iglarlixi is better than that of Lantus will undoubtedly get a wrong judgment In addition, it is not easy for patients who are being treated with ricilar or Lantus alone to switch to their compound drug, iglarlixi In order to fill the sales revenue hole of Lantus falling from the patent cliff, Sanofi did everything possible For example, it cooperated to promote alfredman who inhaled insulin, entered into a $4.2 billion deal with South Korea and the United States pharmaceutical industry (an advance of $432 million) to buy efpeglenide, a long-term GLP-1 agonist, and long-term insulin to expand the pipeline The new CEO, grand Olympic, even publicly threatened to acquire medviation maliciously But it also includes the $245 million deal to buy a priority review voucher at will The external sales forecast for iglarlixi is $574 million in 2020 Judging from the serious statement of the reviewers, Sanofi may waste this high price priority review voucher Of course, the waste we are talking about is not that the FDA will refuse to approve the listing of iglarlixi, but that Sanofi's original expectation that iglarlixi will be listed as soon as possible within six months to buffer the impact of the expiration of Lantus patent will fail Of course, the final result will not be known until the scheduled approval time limit (August 23) The FDA is also in the process of approving lyxumia's listing application, which is scheduled for July this year The FDA advisory committee expressed the same concern on 23 th about IDEG lira of Novo Nordisk, believing that the fixed dose combination of the two lost the flexibility of clinical medication In addition, tresiba and Victoza alone have a high safety, but the use of ideglira may lead to a lack of intake of lilalutide, which will bring new safety problems Sanofi may feel better if he thinks that Nord and Nord are in the same fate However, if you think about it more carefully, FDA has reached a new height in the consideration of safety in the approval of new drugs for urinary diseases Now, it has expressed safety concerns about two drugs with the same mechanism combination Sanofi may take some time to pass the customs successfully Nord and Nord don't say anything about making up the test Sanofi doesn't know how long he will be upset if he wastes this sky high price review voucher
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