Home > Neurology > Biogen pulls application for Alzheimer’s drug in Europe

Biogen pulls application for Alzheimer’s drug in Europe


Notice: Undefined index: new_doi_fields in /home/daan/projects/medicalconferences_dev/wp-content/themes/writers-blogily-child/template-parts/content-structured.php on line 22

Notice: Trying to access array offset on value of type null in /home/daan/projects/medicalconferences_dev/wp-content/themes/writers-blogily-child/template-parts/content-structured.php on line 22

Notice: Trying to access array offset on value of type null in /home/daan/projects/medicalconferences_dev/wp-content/themes/writers-blogily-child/template-parts/content-structured.php on line 22
Reuters - 22/04/2022 - Biogen Inc said on Friday it will withdraw the marketing application for its controversial Alzheimer's drug, aducanumab, in Europe after the U.S. biotech company failed to convince the European regulator of the treatment's benefits. The drugmaker said the move follows interactions with the European Medicines Agency that suggested data provided so far would not be enough to support an approval. The agency in December rejected the drug, and Biogen had sought a re-examination of its decision. "We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound," said Priya Singhal, Biogen's interim head of research. The drug was approved in the United States last June, a controversial decision since only one of two late-stage trials showed that it helped slow cognitive decline. The Food and Drug Administration's own...


Please login to read the full text of the article.


If you have no account yet, please register now.





Posted on