Biogen pulls PRIME designation for aducanumab in Europe; Merck closes merger with Acceleron
Paul Schloesser
Associate Editor
Zachary Brennan
Senior Editor
Following news last week that Biogen received “a negative trend vote” in Europe for its controversial Alzheimer’s drug aducanumab, the company has officially pulled out of the EU’s priority medicines scheme, known as PRIME.
First granted entry into the PRIME program back in May 2016, the EMA said recently that aducanumab’s PRIME eligibility was withdrawn at the request of Biogen. The EMA also noted that Biogen’s Phase III trials have been discontinued, likely lessening the odds that Biogen would re-submit its application in Europe.
The negative news for Biogen follows an extremely slow start in selling the infused drug in the US. But the Cambridge, MA-based biotech is still awaiting a major decision from the Centers for Medicare and Medicaid Services on whether the US federal government will pay for use of the drug. A draft of that decision is expected on Jan. 12. — Zachary Brennan
Paul Schloesser
Associate Editor
Zachary Brennan
Senior Editor
Following news last week that Biogen received “a negative trend vote” in Europe for its controversial Alzheimer’s drug aducanumab, the company has officially pulled out of the EU’s priority medicines scheme, known as PRIME.
First granted entry into the PRIME program back in May 2016, the EMA said recently that aducanumab’s PRIME eligibility was withdrawn at the request of Biogen. The EMA also noted that Biogen’s Phase III trials have been discontinued, likely lessening the odds that Biogen would re-submit its application in Europe.
The negative news for Biogen follows an extremely slow start in selling the infused drug in the US. But the Cambridge, MA-based biotech is still awaiting a major decision from the Centers for Medicare and Medicaid Services on whether the US federal government will pay for use of the drug. A draft of that decision is expected on Jan. 12. — Zachary Brennan