•   
  •   
  •   

Politics FDA approves much-debated Alzheimer’s drug panned by experts

19:06  07 june  2021
19:06  07 june  2021 Source:   msn.com

Aducanumab: FDA approves first new Alzheimer's drug in nearly 20 years

  Aducanumab: FDA approves first new Alzheimer's drug in nearly 20 years The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment. © Dominick Reuter/AFP/Getty Images A sign for biotechnology company, Biogen, Inc. is seen on a building in Cambridge, Massachusetts, on March 18, 2017.

WASHINGTON (AP) — Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.

In this undated image from video provided by Biogen in May 2021, vials of the medication aducanumab are handled by machines during manufacturing in Switzerland. On Monday, June 7, 2021, the Food and Drug Administration approved aducanumab, the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP) © Provided by Associated Press In this undated image from video provided by Biogen in May 2021, vials of the medication aducanumab are handled by machines during manufacturing in Switzerland. On Monday, June 7, 2021, the Food and Drug Administration approved aducanumab, the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP)

The Food and Drug Administration said it granted approval to the drug developed by Biogen for patients with Alzheimer's disease.

Overnight Health Care: FDA approves first Alzheimer's treatment since 2003 in controversial decision | Biogen's CEO defends the $56,000 price tag | Biden hits crunch time on vaccinations

  Overnight Health Care: FDA approves first Alzheimer's treatment since 2003 in controversial decision | Biogen's CEO defends the $56,000 price tag | Biden hits crunch time on vaccinations Welcome to Monday's Overnight Healthcare. A good indication that there are too many bugs around is when they show up on the weather radar. If you have any tips, email us at nweixel@thehill.com, psullivan@thehill.com, and jcoleman@thehill.com Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8. Today: The FDA approved the first Alzheimer's treatment in nearly 20 years - but there's not a lot of evidence that it works. It's also priced extremely high. Meanwhile, President Biden is hitting crunch time to get the U.S. to his July Fourth goal.

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

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.

In this 2019 photo provided by Biogen, a researcher works on the development of the medication aducanumab in Cambridge, Mass. On Monday, June 7, 2021, the Food and Drug Administration approved aducanumab, the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP) © Provided by Associated Press In this 2019 photo provided by Biogen, a researcher works on the development of the medication aducanumab in Cambridge, Mass. On Monday, June 7, 2021, the Food and Drug Administration approved aducanumab, the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP)

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

Biogen CEO says $56K a year for new Alzheimer's drug is a 'fair' price

  Biogen CEO says $56K a year for new Alzheimer's drug is a 'fair' price Biogen CEO Michel Vounatsos on Monday said in an interview that he believed charging $56,000 per year for his company's newly-approved Alzheimer's medication was "fair," citing years of "no innovation" in the marketplace.Appearing on CNBC's "Power Lunch," Vounatsos said the price of the drug, sold as Aduhelm, was a reflection of "two decades of no innovation," and said it would allow Biogen to fund medications for other diseases.He also vowed that his company would not raise the price of Aduhelm for at least the next four years.

The FDA's top drug regulator acknowledged in a statement that “residual uncertainties” surround the drug, but said Aduhelm's ability to reduce harmful clumps of plaque in the brain “is expected” to help slow dementia.

Under terms of the approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm 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.

A preliminary analysis by one group found that the drug would need to be priced $2,500 to $8,300 per year to be a good value based on the “small overall health gains” suggested by company studies. The non-profit Institute for Clinical and Economic Review added that “any price is too high” if the drug’s benefit isn’t confirmed in follow-up studies.

FDA Approves Tembexa to Fight Weaponized Smallpox Virus Amid Fears of COVID Lab Origins

  FDA Approves Tembexa to Fight Weaponized Smallpox Virus Amid Fears of COVID Lab Origins The virus that causes smallpox, the variola virus, is still being kept in two labs—one in Atlanta, Georgia and the other in Russia. The U.S. Food and Drug Administration (FDA) on Friday approved the drug Tembexa to treat smallpox, which is a contagious disease that's sometimes fatal. Concerns of the variola virus have become even more heightened with fears of the COVID-19 coronavirus originated from a science lab."Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S.

Nearly 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more Baby Boomers progress further into their 60s and 70s.

Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) helps clear a protein linked to Alzheimer's, called beta-amyloid, from the brain. Other experimental drugs have done that before but they made no difference in patients’ ability to think, care for themselves or live independently.

The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments, representing billions in research costs. The FDA’s greenlight is likely to revive investments in similar therapies previously shelved by drugmakers.

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

Overnight Health Care: Biden says US donation of 500 million vaccines will 'supercharge' global virus fight | Moderna asks FDA to clear COVID-19 vaccine for adolescents

  Overnight Health Care: Biden says US donation of 500 million vaccines will 'supercharge' global virus fight | Moderna asks FDA to clear COVID-19 vaccine for adolescents Welcome to Thursday's Overnight Health Care. Have you ever wished you could wear your Crocs to a formal event? The luxury brand Balenciaga is partnering with the footwear company to make a high-heeled version of the shoe. But it could cost you as much as $1,000. If you have any tips, email us at nweixel@thehill.com, psullivan@thehill.com and jcoleman@thehill.com.Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8.Today: Moderna filed for authorization to use its COVID-19 vaccine in adolescents.

Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement that the brain plaque targeted by aducanumab is just one factor. Growing evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role.

“This is just one piece of the puzzle and I think all these other options need to be explored and amplified,” said Dr. Ronald Petersen, a Mayo Clinic dementia specialist who has consulted for Biogen and other drugmakers.

Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a sham treatment.

But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details.

The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts have warned that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.

Challenge to Roe v. Wade puts spotlight on FDA review of abortion pill rules

  Challenge to Roe v. Wade puts spotlight on FDA review of abortion pill rules The FDA decision to allow patients to receive the pills via telemedicine or through the mail during the pandemic has galvanized both sides of the abortion wars. Anti-abortion activists — having lost influence in Washington following the 2020 election — have intensified lobbying right-leaning state legislatures to curb, if not outlaw, access to the pills, concerned that widespread access to the drug will render other abortion restrictions obsolete. “In our view, this is Roe 2.

The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed that the drug was effective.

Cambridge, Massachusetts-Biogen halted two studies of the drug in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer's patients.

Several months later, the company reversed course, announcing that a new analysis of one of the studies showed the drug was effective at higher doses and that the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease.

But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising the skepticism of many experts, including those on the FDA panel.

The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions.

In 2016, the agency gave the go-ahead to the first drug for muscular dystrophy despite its expert panel voting that a study in 12 patients had failed to show effectiveness.

In that case, an internal dispute among agency scientists was ultimately decided by the agency’s longtime drugs director, Dr. Janet Woodcock, who is now serving as acting commissioner. Her official decision concluded the drug was “reasonably likely” to benefit some patients. Nearly five years later, the drug’s benefits have still not been confirmed by an FDA-mandated follow-up study.

About 600 U.S. medical specialists took part in Biogen’s studies of the drug and many more are expected to begin offering it. Many practical questions remain unanswered: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia?

With FDA approval, aducanumab is certain to be covered by virtually all insurers, including Medicare, the government plan for seniors that covers more than 60 million people.

Both the FDA and Medicare are barred from considering cost when reviewing a new drug or treatment.

Even qualifying for the drug could be expensive. It’s only been tested in people with mild dementia from Alzheimer’s or a less severe condition called mild cognitive impairment. To verify a diagnosis could require brain scans that cost $5,000 or more. Insurers including Medicare don’t cover the scans because their benefits are unclear, but that could change if the scans become a gateway to treatment. Additional scans will be needed to monitor potential side effects, including brain swelling and bleeding.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Wife of drug kingpin 'El Chapo' pleads guilty to US charges .
WASHINGTON (AP) — The wife of Mexican drug kingpin Joaquin “El Chapo” Guzman pleaded guilty Thursday to charges in the U.S. and admitted that she helped her husband run his multibillion-dollar criminal empire. Emma Coronel Aispuro, wearing a green jail uniform, appeared in federal court in Washington and pleaded guilty to three federal offenses as part of a plea deal with federal prosecutors. The charges include knowingly and willfully conspiring to distribute heroin, cocaine, marijuana and methamphetamine for several years. She also pleaded guilty to a money-laundering conspiracy charge and to engaging in transactions with a foreign narcotics trafficker.

usr: 0
This is interesting!