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Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

Manchin also voiced concerns about the ongoing lack of permanent leadership as Dr. Janet Woodcock continues to serve as acting commissioner of the agency. Woodcock began her tenure as acting commissioner after Biden’s inauguration. She has worked at the agency since 1986.

Manchin asked Biden to make the FDA explain why it chose to ignore the advice of an external advisory committee, which had recommended that the agency not approve the drug without additional data.

Three members of that advisory committee have since…

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

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Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…

Unraveling aducanumab’s impact on pharma remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are six million Alzheimer’s people in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The survey bodes well for the early uptake of the drug, according to Jefferies. But the continued success of aducanumab will require winning over skeptical neurologists and psychiatrists. Several physicians have penned op-ed’s voicing their resistance to the drug in outlets ranting from STAT to the Baltimore Sun. Last Novembe…

Three members of FDA advisory committee resign after aducanumab approval

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.

Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)

Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.

The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).

The three have not gone quietly.

In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”

Knopman told The Washington Post that he did not “wish to be part of a sham process.”

Perlmutter was mor…

Biogen’s stock pops nearly 40% after FDA’s Alzheimer drug approval, but questions remain

FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.

It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.

But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brune…

Biogen Q1 earnings beat estimates, raises EPS guidance

Biogen (NASDAQ: BIIB) posted first-quarter results that beat analysts’ consensus forecast. The company raised its earnings guidance, but the outlook for the rest of the year largely hinges on FDA decisions regarding its pipeline drugs aducanumab and zuranolone.

The Cambridge, Mass.-based biotech reported revenue of $2.69 billion for the quarter ended March 31, 2021, which is a decrease of 24% compared with the same quarter in 2020.

Adjusted to exclude one-time items, earnings per share were $5.34 on sales of $2.69 billion. Analysts at Canaccord Genuity were looking for EPS of $5.06 on sales of $2.68 billion. The consensus forecast was also for EPS of $5.06.

[Related: Biogen moves forward with aducanumab launch plans]

“Our first quarter 2021 results were consistent with our expectations across MS, SMA, and biosimilars despite increased competition,” said CEO Michel Vounatsos in a statement.

The company’s sales of Tecfidera, Spinraza and bios…

Biogen moves forward with aducanumab launch plans

Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug.

FDA reviewers had previously assessed the drug’s prospects more positively.

The company is preparing for the event of an FDA approval of the drug in June.

Biogen’s CEO Michel Vounatsos said in an analyst call today that he expects the antibody drug to sell well given the surging numbers of Alzheimer’s patients in the U.S. and elsewhere. “We anticipate if approved, there will be a large influx of patients,” Vounatsos concluded.

The company has argued that aducanumab slows disease progression in Alzheimer’s patients, which is a feat that no other FDA-approved drug can manage. But critics have argued that the company has failed to demonstrate that the drug is effective and have expressed concern over the drug’s potential to cause amyloi…