The U.S. Food and Drug Administration (FDA) has given early, conditional approval for a new drug that treats and may slow the progression of Alzheimer's, a disease that is thought to affect millions of Americans.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, Dr. Billy Dunn. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Leqembi, developed by Eisai Co. and Biogen Inc., was approved using the FDA's Accelerated Approval pathway, which allows the agency to approve drugs for serious conditions when there is an "unmet medical need and a drug is shown to have an effect," according to the FDA.

"The results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported and the agency anticipates receiving the data soon," they explained in their press release.

However, it may still take a while for patients to have access. According to the Wall Street Journal, a recent Medicare ruling prevents it from being covered.

At least in the near-term, however, Leqembi and other anti-amyloid drugs will be out of reach for most patients because of a Medicare decision in April 2022 to deny routine coverage of such drugs.

Under current Medicare rules, patients must be enrolled in approved clinical trials to get the drug paid for. No such studies are ongoing or planned, according to an Eisai spokeswoman.

Medicare officials can reconsider their coverage decision, but the process could take as long as six to nine months.

According to Eisai, the drug's price comes out to about $26,500 per year.

That's a steep price before insurance, and it's not clear what insurance will and won't cover at this time.

This isn't the first time that the FDA has given approval to a drug that could fight Alzheimer's. The agency granted early approval to the anti-amyloid drug Aduhelm in June 2021, but the move was widely criticized because it relied on data from two questionable studies.

As a result of that experience, the FDA's approval language for Leqembi is tighter, with the agency hoping to avoid repeating that mistake. The studies backing Leqembi are both hailed as well-run and accurate.

But it's good news for those who are affected by the disease.

It's estimated that roughly six million Americans have the disease, which causes cognitive, motor, and systemic declines as it attacks the brain.

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Stacker consulted 2021 data from the NOAA's State Climate Extremes Committee (SCEC) to illustrate the hottest and coldest temperatures ever recorded in each state. Each slide also reveals the all-time highest 24-hour precipitation record and all-time highest 24-hour snowfall.

Keep reading to find out individual state records in alphabetical order.

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