FDA’s approval of aduhelm drug marred by controversy following resignations by three FDA panel members

US – Aduhelm was the first of its kind drug for Alzheimer’s disease to be approved in two decades under the accelerated approval by Food & Drug Association (FDA), however, post its approval period the drug was met with a lot of back lash as many experts were dubious about its functionality.

Its approval by the FDA saw three panel members of the association exit and one among the three members, Dr Aaron Kesselheim of Harvard-affiliated Brigham and women’s hospital, wrote in his resignation letter that the drug was among the worst ever approved in the history of USA.

The drug was still under the clinical trial phase and how its approval status went from trial phase to accelerated approval despite data from the previous clinical trials relaying subpar data puzzled a lot of health experts.

Under the approval Biogen was set to witness massive gains through profit generation of the drug with Aduhelm expected price standing at US$56,000 annually.

The upsurge of this controversy will however see Biogen lose a grip on the Alzheimer’s drug market despite loosing its grip on two of its leading drugs Spinraza and Tecfidera.

Spinraza, a treatment for neuromuscular disorders, is facing competition from a newly introduced drug from Roche as Tecfidera, a multiple sclerosis drug, is facing stiff competitions from generic drugs that have flooded the market.

Just a few days back, the Institute for Clinical and Economic Review (ICER) held an open forum debate in reference to the drugs cost and experts voted 15 to 0 that Aduhelm doesn’t provide benefits above routine care.

ICER experts weren’t the only ones to bring criticisms to the contentious meeting. In an equally-sharp rebuke, Biogen representatives blasted ICER’s cost-effectiveness estimates, which value Aduhelm at $8,400 per year at most.

Biogen’s top medical officer, Maha Radhakrishnan, M.D., argued that evaluating the med would require “innovative thinking” and a new framework to assess its potential value.

In just a matter of weeks, regulators have narrowed Aduhelm’s label and called for an independent investigation into the reportedly cozy dealings between Biogen execs and FDA personnel.

Aduhelm’s list price came in way above ICER’s suggestions and Wall Street estimates, and it doesn’t include the PET scans and MRIs patients need alongside their infusions.

Some major hospital systems are refusing to administer the drug, and insurers are delaying their coverage plans until Medicare makes a move.

The government-run insurance plan opened a National Coverage Determination (NCD) analysis on Monday that will eventually decide whether Medicare will cover the pricey treatment.

The ICER experts based their unfavorable review mostly on Biogen’s conflicting late-stage clinical trials. While one trial showed a modest benefit in slowing disease progression, the other trial found the opposite. Frequent reports of brain swelling, or ARIA, were also a concern, although most cases were asymptomatic.

Biogen, for its part, slammed ICER for pooling data from the two trials together in its model, suggesting that only the positive phase 3 readout should be included.

The drugmaker focused much of its rebuke on Aduhelm’s proven ability to remove amyloid plaque in the brain, a hallmark of Alzheimer’s disease.

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