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Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting. Emend is used in patients aged from 6 months to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
The indication applied for EMEND by the Applicant is “prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin, in combination with other antiemetic agents”.
How does Emend work? Aprepitant, the active substance in Emend, is a neurokinin 1 (NK1) receptor antagonist. It prevents a chemical in the body (substance P) from attaching to the NK1 receptors. When substance P attaches to these receptors, it causes nausea and vomiting. By blocking the receptors, Emend can prevent nausea
1 paź 2019 · Introduction. When developing bio-enabling formulations, innovative tools are required to understand and predict in vivo performance and may facilitate approval by regulatory authorities. EMEND® is an example of such a formulation, in which the active pharmaceutical ingredient, aprepitant, is nano-sized.
On 16 March 2017, the MAH submitted a completed paediatric study for Emend, in accordance with Article 46 of Regulation (EC) No1901/2006, as amended. These data are also submitted as part of the follow up measure(s). A short critical expert overview has also been provided.
A study design is called “adaptive” if statististical methodology allows the modifcation of a design element (e.g., sample size, randomisation ratio, number of treatment arms) at an interim analysis with full control of the type I error. Principles underlying EMA / FDA Guidance.
20 lis 2018 · In order to better understand how adaptive trials are implemented in practice and how they may impact medicine approval within the EMA centralised procedure, we followed on 59 medicines for which an adaptive clinical trial had been submitted to the EMA Scientific Advice (SA) and analysed previously in a dedicated EMA survey of scientific advice ...
