Experts Call For FDA Safety Review Of Alzheimer’s Drug Lecanemab
Axios says the health experts' concerns center around fast-track approval of Eisai's lecanemab and whether the FDA is "cutting corners" in evaluating Alzheimer's treatments. In other news, a pill for postpartum depression is "on the horizon," the safety of at-home brain stimulation, and more.
Axios:
Health Experts Want FDA Safety Review Of Fast-Tracked Alzheimer's Drug
Doctors and scientists are urging the Food and Drug Administration to convene an expert panel to review safety concerns around an Alzheimer's drug that won fast-track approval in January. It's the latest concern over whether the FDA is cutting corners evaluating Alzheimer's drugs, prompted by its controversial 2021 approval of Biogen's Aduhelm, which came over the objections of an advisory panel and without evidence the drug actually slowed the decline of memory and brain function. (Gonzalez, 2/6)
Fox News:
First Drug Proven To Slow Alzheimer's Won't Be Available To Most Patients For Several Months
The first drug proven to slow Alzheimer’s is on sale, but most U.S. patients will not be able to receive the treatment for several months. Experts say some reasons behind the slow debut for Leqembi, from Japanese drugmaker Eisai, are minimal insurance coverage and many health systems requiring a setup that takes a long time. (Mion, 2/6)
In other pharmaceutical news —
The Boston Globe:
A Pill For Postpartum Depression Is On The Horizon
Stephanie Hathaway knows the agony of postpartum depression all too well, having been tormented by intrusive suicidal thoughts after each of her two daughters were born. Both bouts were excruciating, but the second, in 2017, was unremitting. (Cross and Saltzman, 2/4)
NBC News:
Women Suing J&J Speak Out After Company's Failed Legal Maneuver
Plaintiff Deborah Smith’s case was held up for 15 months because of the attempted maneuver, a legal strategy colloquially known as the Texas Two-Step. J&J’s approach relied on the creation of a subsidiary called LTL Management that could take on the liability for talc-related legal claims. Within days of its creation in 2021, LTL filed for Chapter 11 bankruptcy. (Bendix and Wile, 2/4)
Fortune:
Cancer Vaccines Are Already A Reality—But Your Doctor Might Not Tell You About Them Unless You Ask
Doctors don’t always offer cancer-preventing or cancer-treating vaccines to patients—due to lack of knowledge, or bias against certain racial, gender, or age groups. “Patients need to advocate for themselves,” says Dr. Nina Bhardwaj, director of immunotherapy at the Vaccine and Cell Therapy Laboratory and co-director of the Cancer Immunology Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York City. (Prater, 2/4)
NBC News:
At-Home Brain Stimulation: Brain Zapping Devices To Improve Focus Grow In Popularity
In 2021, Craig Gibbons was diagnosed with Lyme disease. His doctor prescribed him antibiotics, but the medication failed to eliminate one of his most debilitating symptoms: a lasting brain fog that made it difficult for him to focus or recall information. So he went with a different approach: at-home brain stimulation. (Lovelace Jr., 2/4)
