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Biogen (BIIB) Up as FDA Approves Alzheimer'S Drug Aducanumab
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Biogen (BIIB - Free Report) and its Japanese partner Eisai announced that the FDA granted accelerated approval to aducanumab, their controversial investigational treatment for Alzheimer’s disease.
The drug, to be marketed by the brand name of Aduhelm, has been approved to reduce the accumulation of amyloid beta plaques, a sticky protein, in the brain, which is believed to lead to progression of Alzheimer’s disease. The approval was based on data from the ENGAGE and EMERGE phase III studies and the phase Ib PRIME study in patients with early-stage Alzheimer’s disease. Data from these studies showed that Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment.
To gain continued approval, Biogen will have to verify the clinical benefit of the drug in a confirmatory study. The drug will reportedly cost $56,000 a year. The drug’s label includes a warning for amyloid-related imaging abnormalities (ARIA), which generally mean temporary swelling in areas of the brain that usually resolves over time.
Biogen’s shares rallied 38.3% on Monday, after FDA approval was announced. Biogen’s shares have risen 61.6% this year so far against the industry’s decrease of 4% in the same time frame.
Image Source: Zacks Investment Research
A Ray of Hope for Alzheimer’s Community
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. Several large pharma companies, including Roche (RHHBY - Free Report) , Amgen (AMGN - Free Report) , Novartis (NVS - Free Report) , 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, the companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market.
Aduhelm has 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. It should bring in huge revenues for Biogen by meaningfully changing the course of Alzheimer’s treatment.
A Rollercoaster Ride for Aduhelm
Interestingly, the FDA approved Aduhelm despite an FDA advisory committee voting against its approval in November last year. The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee voted 8 to 1 with 2 uncertain that data from the EMERGE study on aducanumab (which had met the primary endpoint) does not provide strong evidence to support the efficacy of aducanumab for treating Alzheimer’s when viewed independently, regardless of data from the ENGAGE study (did not meet primary endpoint). The experts voted 10 to 0 with 1 uncertain that EMERGE could be used as primary evidence of efficacy in light of the negative ENGAGE study. The committee also voted against the PRIME study, providing supportive evidence of aducanumab’s effectiveness.
In March 2019, Biogen/Eisai had 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 a 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.
Nevertheless, Biogen said that data from a subset of patients in the ENGAGE study who received a higher dose of aducanumab supported the findings from the EMERGE study. In August 2020, the FDA had granted priority review to Biogen’s application seeking approval of aducanumab. In January 2021, the FDA extended the review period of aducanumab by three months and said will now give its decision on Jun 7.
There was a 50/50 chance of FDA approval of aducanumab. Some analysts believed that the FDA may not approve aducanumab particularly with mixed outcome results across the two studies. However, another group of analysts were in favor of the drug getting approved despite the mixed data on the basis of the drug’s ability to remove amyloid from the brain and its potential to provide meaningful benefit in preventing progression of this disease
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Image: Bigstock
Biogen (BIIB) Up as FDA Approves Alzheimer'S Drug Aducanumab
Biogen (BIIB - Free Report) and its Japanese partner Eisai announced that the FDA granted accelerated approval to aducanumab, their controversial investigational treatment for Alzheimer’s disease.
The drug, to be marketed by the brand name of Aduhelm, has been approved to reduce the accumulation of amyloid beta plaques, a sticky protein, in the brain, which is believed to lead to progression of Alzheimer’s disease. The approval was based on data from the ENGAGE and EMERGE phase III studies and the phase Ib PRIME study in patients with early-stage Alzheimer’s disease. Data from these studies showed that Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment.
To gain continued approval, Biogen will have to verify the clinical benefit of the drug in a confirmatory study. The drug will reportedly cost $56,000 a year. The drug’s label includes a warning for amyloid-related imaging abnormalities (ARIA), which generally mean temporary swelling in areas of the brain that usually resolves over time.
Biogen’s shares rallied 38.3% on Monday, after FDA approval was announced. Biogen’s shares have risen 61.6% this year so far against the industry’s decrease of 4% in the same time frame.
A Ray of Hope for Alzheimer’s Community
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. Several large pharma companies, including Roche (RHHBY - Free Report) , Amgen (AMGN - Free Report) , Novartis (NVS - Free Report) , 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, the companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market.
Aduhelm has 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. It should bring in huge revenues for Biogen by meaningfully changing the course of Alzheimer’s treatment.
A Rollercoaster Ride for Aduhelm
Interestingly, the FDA approved Aduhelm despite an FDA advisory committee voting against its approval in November last year. The Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee voted 8 to 1 with 2 uncertain that data from the EMERGE study on aducanumab (which had met the primary endpoint) does not provide strong evidence to support the efficacy of aducanumab for treating Alzheimer’s when viewed independently, regardless of data from the ENGAGE study (did not meet primary endpoint). The experts voted 10 to 0 with 1 uncertain that EMERGE could be used as primary evidence of efficacy in light of the negative ENGAGE study. The committee also voted against the PRIME study, providing supportive evidence of aducanumab’s effectiveness.
In March 2019, Biogen/Eisai had 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 a 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.
Nevertheless, Biogen said that data from a subset of patients in the ENGAGE study who received a higher dose of aducanumab supported the findings from the EMERGE study. In August 2020, the FDA had granted priority review to Biogen’s application seeking approval of aducanumab. In January 2021, the FDA extended the review period of aducanumab by three months and said will now give its decision on Jun 7.
There was a 50/50 chance of FDA approval of aducanumab. Some analysts believed that the FDA may not approve aducanumab particularly with mixed outcome results across the two studies. However, another group of analysts were in favor of the drug getting approved despite the mixed data on the basis of the drug’s ability to remove amyloid from the brain and its potential to provide meaningful benefit in preventing progression of this disease
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>