FDA Neuroscience Chief Billy Dunn Departs, Leaving a Lasting Legacy

After a tumultuous tenure, FDA neuroscience head Dr. Billy Dunn is leaving his post to pursue other opportunities. An internal FDA e-mail revealed the news, which comes amid considerable controversy surrounding Dunn’s leadership.

After nearly 18 years of service to the FDA, Dr. Billy Dunn announced his plans to retire on Friday, according to a source speaking to STAT News. Dunn, who joined the FDA’s Office of Neurological Products in 2005, has been a crucial part of the agency for many years. His retirement marks the end of an era at the FDA.

Teresa Buracchio, formerly the deputy director of the Office of Neuroscience, will now be stepping into the director role in an acting capacity, per the announcement from Peter Stein, head of the FDA’s Office of New Drugs. Buracchio’s new role is effective immediately.

After a remarkable career dedicated to public service, Billy has decided to retire from FDA and embark on a new journey while still dedicating himself to improving the lives of those struggling with neurological diseases. He is leaving behind a legacy of significant contributions to the betterment of public health.

The FDA’s recent decision to approve Biogen and Eisai’s Alzheimer’s drug, Aduhelm, has sparked widespread controversy in the medical community, with the Peripheral and Central Nervous System Drugs Advisory Committee voicing its vehement opposition to the drug’s approval. This controversy has centered around Dr. Richard P. Dunn, the lead reviewer of the drug’s application.

In June 2021, the FDA made history by approving Aduhelm, the first drug to treat Alzheimer’s in 18 years. The decision was controversial, however, due to the reported close ties between Biogen, the company behind Aduhelm, and Dr. Alfred Dunn, a prominent Alzheimer’s researcher. This approval marks an important milestone in the fight against Alzheimer’s, offering hope to millions of patients and their families.

In January 2023, Leqembi (lecanemab), the partners’ second Alzheimer’s drug, was granted accelerated approval to much less controversy than their first drug. This could be due to the impressive evidence of amyloid clearing the drug displayed.

The following day, Eisai and Biogen submitted an application for full traditional approval of Leqembi. With an expectation of full approval as soon as summer 2023, both companies are eagerly awaiting the results.

As the era of Dunn draws to a close, the question of whether to grant traditional approval to Eli Lilly’s donanemab remains up in the air. Despite its failure to win an accelerated nod in January, the decision now lies in the hands of either Buracchio or another successor.

2023 promises to be an exciting year for the Office of Neuroscience. In March, Biogen’s tofersen for superoxide dismutase 1 (SOD1) ALS will face a crucial adcomm meeting ahead of an April 25 PDUFA date, while Acadia Pharmaceuticals has a review date of March 12 for trofinetide as a treatment for Rett syndrome. With the potential for these groundbreaking treatments to become available, the Office of Neuroscience stands at the forefront of a new era of medical research and discovery.

Reata Pharmaceuticals is on the cusp of a major breakthrough: a decision on Feb. 28 that could potentially approve omaveloxolone as the first treatment for Friedreich’s ataxia. If approved, this would be a monumental leap forward in medical science, providing hope to those living with the rare neurological disorder.

Investors were rattled after Reata’s stock plummeted 34% following Dunn’s departure, leaving the pending approval hanging in the balance.

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