Biogen Inc. BIIB announced that it has completed submission of the biologics license application (BLA) to the FDA seeking approval of aducanumab, its controversial investigational treatment for Alzheimer’s disease. The completed BLA filing includes data from the ENGAGE and EMERGE phase III studies as well as the phase Ib PRIME study in patients with early-stage Alzheimer’s disease.
Biogen’s shares were up 4.4% on Wednesday as the BLA filing removed significant uncertainty regarding the regulatory filing timeline of aducanumab. Biogen’s shares have declined 5.5% against the industry’s increase of 11.8% in the same time frame.
In March 2019, Biogen and its Japan-based partner Eisai announced the discontinuation of ENGAGE and EMERGE studies as a futility analysis showed that these were unlikely to meet their primary endpoints. In October 2019, surprisingly, Biogen revealed plans to pursue U.S. regulatory approval of aducanumab based on positive results of a new analysis of larger dataset, which became available after the discontinuation of the studies.
The new analysis of the larger dataset showed a different outcome than the one predicted at the time of the futility analysis. The EMERGE study met the primary endpoint, showing that patients treated with high dose (10mg/kg) of aducanumab experienced a statistically significant reduction in clinical decline of Alzheimer’s disease. The ENGAGE study, however, did not meet the primary endpoint. However, Biogen said that data from a subset of patients in the ENGAGE study who received higher dose of aducanumab supported the findings from EMERGE study.
In April, the BLA filing timeline for aducanumab was delayed from early 2020 to the third quarter of 2020. The FDA will now decide within 60 days whether to accept the application for review and also grant its priority review status, if accepted. If the application is granted priority review status, the FDA review timeline for aducanumab would be completed within six months of acceptance of the BLA instead of the standard 10 months.
Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging area, and not much progress has been made despite significant investments (both funds and resources). The drugs presently available just treat the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease. Other than Biogen, several large pharma companies, including Roche RHHBY, Amgen AMGN, Novartis NVS, Merck, Pfizer, Lilly and AstraZeneca stopped development of their AD candidates in the last few years either due to low possibility of success or safety concerns.
Despite the setbacks, companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market. Success in this area means huge returns. This is because more than 5 million Americans are living with AD with the numbers expected to triple by 2050 (Data: Alzheimer's Association). The market has immense commercial potential and companies coming out with new treatments could rake in billions of dollars in sales.
No doubt, Biogen has left no stone unturned to resurrect aducanumab because if it is approved by the FDA. It will become the first medicine to be approved to reduce the clinical decline associated with this devastating disease. It will also be the first medicine to show that removing amyloid beta (plaque in the brain) results in better clinical outcomes in Alzheimer’s patients and bring in huge revenue for Biogen.
However, a group of analysts believe that the FDA may not approve aducanumab, particularly with mixed outcome results across the two studies. Also, the FDA may require additional studies to be conducted to confirm the candidate’s benefits.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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