Genmab — November 2017
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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement
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over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."[5][7]
Requests are reviewed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). CDER receives approximately 100 requests per year for breakthrough designation. Historically, about one third were approved. CBER receives 15–30 requests per year.[8] Sponsors must apply for breakthrough
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status separately for each indication they intend to label the drug for.
Breakthrough designation applications are submitted as an amendment to the IND applications before the initiation of clinical trials.[9]
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hvornår har han sagt det, jeg hørte det ikke???
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Det sagde han også i august! Så det skal nok tages med et gran salt.
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sagde han det i går??
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