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Leqembi could mark new era in Alzheimer’s treatment progress: An overview of the evolving drug development scene

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Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit.

The drug, which reduces the formation of amyloid plaques in the brain, is the first of its kind to transition from an accelerated approval to a traditional approval for Alzheimer’s treatment.

Leqembi’s annual launch price is $26,500.

Following approval, lecanemab stands to potentially gain Medicare coverage with qualifications.

The approval of Leqembi is a positive step forward and will spur further advances and investments in Alzheimer’s research, according to Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF).

“We final…

Rethinking treatment options for patients diagnosed with bipolar 1 disorder

The COVID-19 pandemic has contributed to a significant increase in the rates of Americans living with mental illness.1 Meanwhile, medication shortages and a chronic scarcity of mental health professionals added pressure to an already stressed system.2 In this context, pharma companies play a vital role in developing novel therapies for mental health conditions, which can help alleviate the burden on healthcare providers and improve patient outcomes. As a clinical nurse practitioner who treats patients with a variety of mental health conditions, including bipolar 1 disorder, I believe innovative mental health strategies and treatment options, such as Lybalvi for bipolar 1 disorder, need to be considered across the healthcare spectrum.

Bipolar 1 treatment challenges

It is common for patients living with bipolar 1 disorder to be misdiagnosed with, and receive treatment for, major depressive disorder. Furthermore, up to one-third of patients can remain misdiagnosed for te…

What are the most common COVID-19 vaccine side effects?

[Photo by Daniel Schludi on Unsplash]

Now that it has been nearly four months since the FDA authorized the first COVID-19 vaccine, a decent amount of safety information is available about the Pfizer-BioNTech vaccine.

CDC recently released a summary of adverse event data related to the Pfizer-BioNTech vaccine based on more than 5,000 entries to the Vaccine Adverse Event Reporting System collected from Dec. 14, 2020, to Jan. 13.

The summary also included data related to more than 1,000 recipients of the first dose of Moderna COVID-19 vaccine.

The entries make up only a minuscule fraction of the more than 90 million doses of COVID-19 vaccine that Americans have received to date.

A total of 93.7% of the reports related to the first dose of Pfizer-BioNTech vaccine were nonserious, although that figure dropped to 78.6% when it came to the second dose. For the Moderna vaccine, 81.2% of the event…