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Biogen (BIIB) Aducanumab Gets Fast Track Status in the U.S.

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Biogen Inc. BIIB announced that the FDA has granted Fast Track designation for its investigational therapy, aducanumab, for the treatment of early-stage Alzheimer’s disease (AD).

We note that the FDA grants Fast Track status to facilitate the development and expedite the review process for candidates that are being developed for the treatment of serious conditions with unmet medical need.

Aducanumab is in two global phase III studies – ENGAGE and EMERGE – to evaluate its safety and efficacy in slowing cognitive impairment and progression of disability in patients suffering from early-stage AD.

Biogen is also evaluating aducanumab in a phase 1b study (PRIME) to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of the candidate in patients with prodromal or mild AD. Data from the PRIME study demonstrated that aducanumab reduced amyloid-beta in the brain and the reduction was dose dependent.

We remind investors that in Jun 2016, aducanumab was accepted into the European Medicines Agency’s (EMA) Priority Medicines (PRIME) program, which aims to bring treatments to patients faster by enhancing the agency’s support for the development of investigational medicines for diseases without available treatment or in need for better treatment options.

While successful development of therapies for Alzheimer’s disease is quite challenging, the market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.

Last month, Eli Lilly and Company LLY and AstraZeneca plc (AZN - Free Report) gained fast track status in the U.S. for their experimental AD treatment, AZD3293.

AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor, is currently in phase III studies. In addition to the phase II/III study – AMARANTH, patients are being enrolled in a phase III study – DAYBREAK-ALZ, which is evaluating the safety and efficacy of the candidate in people with mild Alzheimer's dementia.

Biogen currently has a Zacks Rank #3 (Buy). Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).

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