BIO chaos, Ozempic, MDMA therapy, Guardant
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Morning! Today, we see some holes in the data for MDMA-assisted therapy, and ponder how that might impact the FDA’s upcoming decision over its approval. Also, the agency’s advisers debate Guardant’s colon cancer liquid biopsy test, and we see new data showing Ozempic’s efficacy in preventing death in diabetes and chronic kidney disease patients.
One programming note: This newsletter is taking a holiday Monday in observance of Memorial Day. Have a fabulous long weekend. Don’t work too hard.
MDMA trials don’t account for patients with negative experiences
MDMA-assisted therapy is on the precipice of a potential FDA approval. But while one small study touted an 83% response rate, that isn’t everyone. One patient reported that she seriously considered suicide while on the phone with her study therapists. “For the first time in a really long time I went, ‘I am done,’” she said. “All that is pounding through my head is: ‘Why am I not that 83%?’”
Incidents like these aren’t reflected in published data from the trial, STAT’s Olivia Goldhill writes. But critics argue that there are inconsistencies and shortcomings in the data that could compromise the integrity of the clinical trials being reviewed by the FDA.
Suicidal ideation was tracked in all studies, a spokesperson for Lykos Therapeutics — the trial’s sponsor — told STAT. But it wasn’t considered an adverse event unless recorded levels of suicidal ideation were higher after the trial than before.
Ozempic cuts risk of death in type 2 diabetes, chronic kidney disease
Ozempic has racked up another clinical trial win: The Novo Nordisk blockbuster slashed the risk of death in patients with type 2 diabetes and chronic kidney disease by 20%. It cut cardiovascular-related deaths by 29%, and lowered the risk of major heart complications by 18%. These data suggest that these GLP-1 drugs could confer advantages to patients over other classes of drugs, STAT’s Elaine Chen writes.
Novo plans to seek FDA approval to expand Ozempic’s usage to treat chronic kidney disease. Wegovy, Novo’s obesity-focused GLP-1 counterpart, recently won approval for cardiovascular risk reduction. Novo is testing Wegovy in heart failure, MASH, and Alzheimer’s.
More tumult at BIO
How does a drug industry lobbying group move forward after years of upheaval, including having four CEOs in four years?
This week on “The Readout LOUD,” STAT’s chief Washington correspondent, Rachel Cohrs Zhang, joins us to discuss the layoffs at trade group BIO and how things may be changing. We also invite STAT reporter Eric Boodman on to talk about his new investigative series of stories exploring how Black women with sickle cell disease were coerced into getting sterilized.
FDA advisers recommend Guardant’s blood-based colon cancer test
An FDA advisory committee yesterday recommended that the agency approve a blood-based colon cancer detection test made by Guardant Health. Of the nine voting members, eight deemed it safe, six considered it effective, and seven believed its benefits outweighed risks.
If regulators do approve the diagnostic, it would pave the way for potential coverage from CMS.
In 2021, CMS declined to cover Epi proColon, an FDA-approved, blood-based colon cancer test made by Epigenomics, STAT’s Angus Chen and Jonathon Wosen write. Soon after the CMS denial, the company said it would stop marketing the test, and last year Epigenomics announced restructuring and layoffs.
But Shield, the test made by Guardant, might be just accurate enough that the FDA and CMS alike will approve it.
