What is the new Alzheimer's drug approved by the FDA?

THE FDA announced their approval of an Alzheimer's disease treatment developed by Biogen that has been met with controversial reception.

Nearly 6 million people in the US and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication, and basic daily tasks.

What is the Alzheimer's drug created by Biogen?

Government health officials approved the first new drug called aducanumab for Alzheimer’s disease in nearly 20 years, despite controversy over the trial results.

It’s the only drug that regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The drug is given as an infusion every four weeks.

The new medicine is made from living cells that will have to be given via infusion at a doctor’s office or hospital.

The most common side effects were inflammation in the brain, most cases did not cause symptoms or lasting problems.

The FDA is requiring the drugmaker to conduct a follow-up study to confirm the drug’s benefits for patients.

If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.

Biogen did not immediately disclose the price, though analysts have estimated the drug could cost between $30,000 and $50,000 for a year’s worth of treatment.

What did the Alzheimer's Association say about Biogen?

Alzheimer’s Association president and CEO Harry Johns said: "On behalf of those impacted by Alzheimer’s and all other dementia, the Alzheimer’s Association welcomes and celebrates today’s historic FDA approval of aducanumab for Alzheimer’s disease.

"This approval is a victory for people living with Alzheimer’s and their families.It is a new day. This approval allows people living with Alzheimer’s more time to live better.

"For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope."

The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups.

It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.

The FDA is requiring the drugmaker to conduct a follow-up study to confirm the drug’s benefits for patients.

If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.

What did people say about the Biogen drug?

Social media users were skeptical of the Biogen announcement and took to Twitter to express their thoughts.

"9 years… a long time to wait for compelling evidence but enough time to make profitable ? we will see what is most important for biogen," one said.

"Biogen shareholders are laughing all the way to the bank," another said.

One Twitter user complained to their representatives about the new drug, writing: "How much is your memory worth… apparently, @biogen thinks it is worth $56,000 a year. @[email protected]@RepColinAllred this is not acceptable. as someone who had two grandparents, and most likely a mother with Alzheimer's, this is unacceptable."

"I'm really glad to see that research like this is being pursued, especially in seemingly unrelated areas (depression, cancer, Alzheimer's). I'm not altogether reassured by Biogen's 'data,'" another commented.

"A 22% reduction in decline, if the Biogen's claims are even true, at $56K a year is obscene," a user said of the cost.

    Source: Read Full Article