Aducanumab: Biogen Is The Latest Firm To Preempt A Negative EU Opinion On Approval
The EU marketing application for aducanumab is heading for a rejection for Alzheimer’s disease, according to a “negative trend vote” at the CHMP disclosed by the drug’s sponsors.
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A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.
Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.
Lilly’s Alzheimer’s Drug Will Get ‘Easier Ride’ Than Aduhelm But Does Not Show Clinical Benefit, Prof Says
Harsh assessment of Lilly’s Phase II study by UCL and UCSF professors suggests donanemab may face same hurdles as Biogen’s Aduhelm. Lilly exec says the drug slowed disease progression by six months, but UCL prof says that won’t make a difference.