WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.”

The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee — Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug.

The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.”

The FDA and Biogen issued statements Thursday defending the Aduhelm approval process.

In 2021, the FDA overruled its own independent scientific advisers when it approved Aduhelm even though research studies failed to prove it really helped patients. Biogen had halted two studies after disappointing results suggested the drug wasn’t slowing Alzheimer’s inevitable worsening — only to later contend that a new analysis of one study showed higher doses offered an incremental benefit.

The FDA argued the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency’s then-acting chief called for an internal investigation. Eventually Medicare refused to pay for the drug — even after the yearly price was dropped to $28,000 — unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline.

Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented. In addition, the regulators and company spent months working together to prepare a briefing document for FDA’s advisers that didn’t adequately represent substantial disagreement within the FDA about how to handle Aduhelm, the report said.

The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers. They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing.

In a statement Thursday, FDA said the Aduhelm decision “was based on our scientific evaluation of the data” and that the agency’s own internal review found its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer’s drug development and will review the investigation’s findings.

In its own statement, Biogen said: “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm” but that it “stands by the integrity of the actions we have taken.”

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Shares of Biogen and other drugmakers researching Alzheimer’s disease soared Wednesday after Japan’s Eisai Co. said its potential treatment appeared to slow the fatal disease in a late-stage study.

The drugmaker said early results showed that its treatment, lecanemab, reduced patient clinical decline by 27% when compared to a placebo or fake drug after 18 months of the infused treatment.

Eisai announced results late Tuesday from a global study of nearly 1,800 people with early-stage Alzheimer’s.

Patients were monitored using a scale that measures mental decline and their ability to do daily activities like getting dressed or feeding oneself.

Eisai Co. Ltd. said it would discuss full results from the research at a conference in late November. It also plans to publish findings in a peer-reviewed medical journal.

The company is already seeking an accelerated approval from the U.S. Food and Drug Administration, and the agency is expected to decide by early next year. Eisai and Biogen will co-promote the drug.

Researchers typically urge caution in evaluating a study until the full results are released. But the initial findings appear to be “quite robust” and will likely support regulatory approval, Mizuho Securities analyst Graig Suvannavejh said in a research note.

A statement from the Alzheimer’s Association called the findings the most encouraging to date for potential treatments of the underlying disease causes.

Some 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.

Alzheimer’s has no known cure. Long-standing treatments on the market just manage symptoms, and researchers don’t fully understand what causes the disease.

Last year, Biogen’s Aduhelm became the first new Alzheimer’s drug introduced in nearly two decades. But it has largely flopped after debuting with a price tag of $56,000 annually, which Biogen later slashed.

Doctors have been hesitant to prescribe it, given weak evidence that the drug slows the progression of Alzheimer’s. Insurers have blocked or restricted coverage due to concerns over the drug’s high price tag and uncertain benefit.

Earlier this year, the federal Medicare program imposed strict limits on who can get the drug, wiping out most of its potential U.S. market. Biogen announced afterward that it would stop most of its spending on the treatment.

Like Aduhelm, lecanemab, which Eisai developed, aims to clear a protein called beta-amyloid from the brain.

The protein forms a plaque that researchers believe is a contributor to Alzheimer’s. They also point to other potential factors like family history and chronic conditions such as diabetes.

Eisai executives say lecanemab focuses more on floating clumps of the protein before it forms the plaque, which is what Aduhelm targets.

Eli Lilly and Co. also is developing a potential treatment, donanemab, that targets the protein.

Shares of Cambridge, Massachusetts-based Biogen Inc. jumped 40% to close Wednesday at $276.61. The stock had largely tumbled since Aduhelm’s debut last year.

Shares of Indianapolis-based Eli Lilly and Co. rose 7.5%.

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