FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug

July 8, 2021 by Dan McCue

U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug.

The announcement came through Biogen Inc., the maker of Aduhelm, which stated the update is intended to “clarify” the patients studied in the company trials that led to approval.

The new labeling approved by the FDA state’s the drug is appropriate for patients exhibiting signs of mild cognitive impairment or mild dementia.

When the drug was first approved a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”

But that led to weeks of blowback and consternation. The FDA then approached the company about narrowing the label and approved the language to address confusion among physicians and patients.

The FDA now warns that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.” 

Biogen’s head of research and development, Dr. Alfred Sandrock, Jr. said the new labeling is based “on our ongoing conversations with prescribing physicians, FDA and patient advocates. 

“We submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” he added.

Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.

The label change comes one month after FDA’s approval of the drug, which quickly sparked controversy over its $56,000-a-year price-tag and questionable benefits. 

Three of FDA’s outside advisers resigned over the decision with one prominent Harvard expert calling it the “worst drug approval decision in recent U.S. history.”

In The News

Health

Voting

Prescription Drugs

Opioid Maker and Distributors Settle State Lawsuits for $26 Billion
Litigation
Opioid Maker and Distributors Settle State Lawsuits for $26 Billion
July 23, 2021
by Tom Ramstack

A coalition of state attorneys general reached a $26 billion settlement with opioid maker Johnson & Johnson and three of its distributors this week. They blame the companies for a half-million deaths in the United States from overdoses and addictions to powerful painkillers. "Our country's opioid... Read More

Pfizer to Discuss Vaccine Booster with US Officials Monday
Health
Pfizer to Discuss Vaccine Booster with US Officials Monday

WASHINGTON (AP) — Pfizer says it plans to meet with top U.S. health officials Monday to discuss the drugmaker's request for federal authorization of a third dose of its COVID-19 vaccine as President Joe Biden's chief medical adviser acknowledged that "it is entirely conceivable, maybe likely"... Read More

Both Sides Lay Cards on The Table on Drug Pricing
Prescription Drugs
Both Sides Lay Cards on The Table on Drug Pricing
July 9, 2021
by Dan McCue

WASHINGTON - A trio of House Democrats, including House Speaker Nancy Pelosi, D-Calif., and Rep. Carolyn Maloney, D-N.Y., chair of the House Committee on Oversight and Reform, accused the nation’s largest pharmaceutical companies on Thursday of being more concerned with “self enrichment” than in the well-being... Read More

FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug
Prescription Drugs
FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug
July 8, 2021
by Dan McCue

U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug. The announcement came through Biogen Inc., the maker of Aduhelm, which stated the update is intended to “clarify” the patients studied in the company trials... Read More

More States Agree to Settlement Plan for Opioid-maker Purdue
Prescription Drugs
More States Agree to Settlement Plan for Opioid-maker Purdue

More than a dozen states have dropped their longstanding objections to OxyContin maker Purdue Pharma's reorganization plan, edging the company closer to resolving its bankruptcy case and transforming itself into a new entity that helps combat the U.S. opioid epidemic through its own profits. The agreement... Read More

Health Summit Panel Debates Drug Pricing Proposals
Prescription Drugs
Health Summit Panel Debates Drug Pricing Proposals
June 30, 2021
by Alexa Hornbeck

Policymakers and representatives of the pharmaceutical industry debated the cost of prescription drugs and the myriad of proposals on Capitol Hill to bring those prices down at last week's Milken Institute Future of Health Summit. Amitabh Chandra, a health care economist at the John F. Kennedy... Read More

News From The Well
scroll top