Story

 - 

FDA to decide on Biogen/Eisai's aducanumab in March

Country : Europe, Japan, U.S.

Keywords :
LONDON, 7 Aug (APM) - Biogen and Japan's Eisai said on Friday the U.S. Food and Drug Administration has accepted their filing for experimental Alzheimer's disease treatment aducanumab, with a decision due by 7 March.
If approved, aducanumab would become the first therapy to reduce the clinical decline associated with Alzheimer's disease and would also be the first therapy to demonstrate that removing amyloid-beta resulted in better clinical outcomes, the companies said in a joint statement.
Analysts have said it has the potential to become a multi-billion dollar blockbuster. The FDA last reviewed an application for a new Alzheimer's treatment 17 years ago.
The companies said the drugs regulator would consult a panel of outside experts on a yet-to-be-determined date for the approval of the medicine. The agency is not required to follow the panel's recommendation, but usually does.
Biogen in October last year revived plans to seek approval for the treatment months after scrapping the development of the drug. The company said then that a new analysis of the discontinued studies, which looked at a larger set of data, showed the drug was "clinically active".(APMHE 68426)
Biogen said in July it is in talks with regulatory authorities in other markets, including Europe and Japan, and is working towards filing applications in these markets. (APMHE 68084)
nh/gj

[NH3QEP1ZS]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.