Det er mit indtryk, når man har hørt interviews med deres CEO, at EMA' beslutning er kommet som et stort chock. Men nok et godt eksempel på, at man aldrig skal føle sig sikker før "præsten har sagt amen".
UPDATE 1-EU medicines regulator rejects Eisai-Biogen Alzheimer's drug
12:40 (Adds background throughout)
July 26 (Reuters) - The European Union's drugs regulator
on Friday rejected Eisai and Biogen's
breakthrough treatment for early Alzheimer's disease, in a blow
to the drugmakers as take-up in the U.S. has been slower than
expected.
The agency's Committee for Medicinal Products for Human Use
said it had recommended not granting an authorization as the
observed benefits did not counterbalance the risk of serious
side events, especially brain swelling and bleeding or
microhemorrhages.
The drug, lecanemab, is sold as Leqembi in the U.S. and was
set to be Europe's first drug to treat the neurodegenerative
condition rather than its symptoms.
It has been under review in the region since January 2023
and gained traditional approval in the U.S. last year. It is
also approved in other countries, including China and Japan.
(Reporting by Manas Mishra and Puyaan Singh in Bengaluru;
Editing by Josephine Mason and Arun Koyyur)
((Puyaan.Singh@thomsonreuters.com;))
UPDATE 1-EU medicines regulator rejects Eisai-Biogen Alzheimer's drug
12:40 (Adds background throughout)
July 26 (Reuters) - The European Union's drugs regulator
on Friday rejected Eisai and Biogen's
breakthrough treatment for early Alzheimer's disease, in a blow
to the drugmakers as take-up in the U.S. has been slower than
expected.
The agency's Committee for Medicinal Products for Human Use
said it had recommended not granting an authorization as the
observed benefits did not counterbalance the risk of serious
side events, especially brain swelling and bleeding or
microhemorrhages.
The drug, lecanemab, is sold as Leqembi in the U.S. and was
set to be Europe's first drug to treat the neurodegenerative
condition rather than its symptoms.
It has been under review in the region since January 2023
and gained traditional approval in the U.S. last year. It is
also approved in other countries, including China and Japan.
(Reporting by Manas Mishra and Puyaan Singh in Bengaluru;
Editing by Josephine Mason and Arun Koyyur)
((Puyaan.Singh@thomsonreuters.com;))
27/7 2024 13:29 Thorkild01 0
121503 ESAI præsenterer ved AAIC resultaterne af et 3 årigt studie af effekten og sikkerheden ved Lecanemab. Bliver interessant at få et muligt indblik i, hvad der (måske) er EMA' CMPH baggrund for at afvise en markedsføringsgodkendelse i EU.
https://www.bioarctic.com/en/long-term-treatment-data-for-lecanemab-to-be-presented-at-aaic-2024/
https://www.bioarctic.com/en/long-term-treatment-data-for-lecanemab-to-be-presented-at-aaic-2024/
27/7 2024 14:48 Thorkild01 0121506 Det får man også, når man holder sig for næsen, når man nyser :D
Da AAIC jo er stedet, hvor den videnskabelige ekspertise inden for Alzheimer's samles og udveksler viden og synspunkter, er jeg ret sikker på, at der vil blive en interessant OQ opfølgning på ESAI' præsentation af deres langtidsstudie, som EMA panelet med ret stor sandsynlighed nok også har haft adgang til og taget med i deres beslutning.
Da AAIC jo er stedet, hvor den videnskabelige ekspertise inden for Alzheimer's samles og udveksler viden og synspunkter, er jeg ret sikker på, at der vil blive en interessant OQ opfølgning på ESAI' præsentation af deres langtidsstudie, som EMA panelet med ret stor sandsynlighed nok også har haft adgang til og taget med i deres beslutning.
