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U.S. Regulators Approve Controversial New Alzheimer’s Drug Aduhelm

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U.S. regulators on Monday approved the first new Alzheimer’s drug in nearly two decades, removing doubts about its effectiveness. Aduhelm is the first new drug to address cognitive decline associated with Alzheimer’s disease.

“Aduhelm is the first treatment to target the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain,” said Patrizia Cavazzoni of the US FDA.

The U.S. Food and Drug Administration FDA based its decision on scientific evidence suggesting that Aduhelm reduces a sticky substance in the brain called amyloid, which has been linked to Alzheimer’s disease and is likely to benefit patients.

The sale of the drug offers hope to millions of Alzheimer’s patients and their carers in the absence of good treatment options. But Aduhelm’s influence may be limited.

Doctors who say they will prescribe the drug warn that it won’t help all patients, especially those with more advanced symptoms of the disease. Cigna Corp. estimates that some patients eligible for treatment can expect annual out-of-pocket expenses of $ 10,000 or more.

Critical time for biotechnology

In addition, some doctors say the evidence of the drug’s effectiveness is limited and is recommended against its approval. The approval comes at a critical time for the biotech company, which is grappling with falling sales and the loss of patent protection for its best-selling drug, Tecfidera, a multiple sclerosis pill.

Biogen expects Aduhelm’s sales to be modest this year as the drug hits the market and grows thereafter. Analysts surveyed FactSet on project revenue of $ 62.7 million in 2021, $ 603.2 million in 2022, and $ 1.6 billion in 2023.

Biogen stock rose 38% after being stopped in Monday’s session, adding $ 16.5 billion in market value. The Nasdaq Biotechnology Index rose 3.6%, its best day since November 4, 2020.

“This historic moment marks the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive of Biogen. “Together with healthcare, we are ready to bring this new drug to patients and begin addressing this growing global health crisis.”

Biogen rated the newly approved drug higher than analysts expected. The company said it would charge about $ 56,000 per patient per year.

A preliminary analysis by the Institute for Clinical and Economic Review, a nonprofit research and advisory group, found the drug could be cost-effective at a price of $ 2,500 to $ 8,300 per patient per year.

Aduhelm’s generic name addanumab

Alzheimer’s is a progressive degenerative disease that is slowly robbing people of their memory and ability to care for themselves. About six million people in the United States have Alzheimer’s disease. According to estimates by Cigna, up to 1.4 million of these could be considered for taking Aduhelm.

Aduhelm, a monoclonal antibody also known by the generic name aducanumab and given intravenously, was tested in two late-stage human studies called phase 3 studies. It showed a reduction in cognitive decline in one but not the other.

But in all of the studies, it convincingly showed a reduction in the accumulation of a protein called beta-amyloid in the brain tissue of Alzheimer’s patients.

One theory suggests that Alzheimer’s disease is due to an excessive build-up of these proteins in the brains of some people as they age and their immune systems decline. Providing antibodies to such patients could therefore be a means of restoring some of their ability to clear plaque buildup.

“We feel determined and responsible to make the hope of today’s FDA approval of Aduhelm a reality for people with Alzheimer’s disease and their families,” said Alisha Alaimo, president of Biogen US, in a statement on Twitter.

Source: WSJ, AFP

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U.S. Hemp Oil Market Analysis, Forecast Analysis to, Analysis, Top Companies’ Growth, Trends by Types and Applications, – The Daily Vale

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US hemp oil market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyzes that the market is growing at a CAGR of 26.8% in the forecast period of 2020 to 2027 and expected to reach USD 4,906.54 thousand by 2027. Hemp oil market is dominating as people are becoming more health conscious and they prefer organic product which is good for health.

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key U.S. Hemp Oil Market Competitors Covered in the Report

Tropical Products

Gaia Herbs

HempLife Today

Diamond CBD

Medix CBD

NuLeaf Naturals, LLC

CV Sciences, Inc.

ConnOils LLC

Medical Marijuana, Inc.

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  • The changing effect on market dynamics: global part provides driving factors, trends, challenges and opportunities; post-COVID analysis.
  • View by type, end user and region/nation.
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  • Regional analysis: Asia Pacific Region to Stand Firm on its Leading Position in the industry.
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Table of Content: Global Menstrual Cramps Treatment Market Research Report

Chapter 1: Global Menstrual Cramps Treatment Industry Overview

Chapter 2: Global Economic Impact on Menstrual Cramps Treatment Market

Chapter 3: Global US Hemp Oil market size competition by industry producers

Chapter 4: Global Productions, Revenue (Value), according to Regions

Chapter 5: Global Supplies (Production), Consumption, Export, Import, geographically

Chapter 6: Global Productions, Revenue (Value), Price Trend, Product Type

Chapter 7: Global US Hemp Oil market Analysis, on the basis of Application

Chapter 8: US Hemp Oil market Industry Value Chain

Chapter 9: Market Chain, Sourcing Strategy, and Downstream Buyers

Chapter 10: Strategies and key policies by Distributors/Suppliers/Traders

Chapter 11: Key Economic Indicators, by Market Vendors

Chapter 12: US Hemp Oil market Effect Factors Analysis

Chapter 13: US Hemp Oil market Market Forecast Period

Chapter 14: Future Of The US Hemp Oil Market

Chapter 15: appendix

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