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Risk of severe hypoglycemia was too much for panel members to overcome

by
Kristen Monaco
,
Senior Staff Writer, MedPage Today

May 24, 2024

An FDA advisory committee mostly agreed on Friday that an investigational once-weekly insulin product carries too much risk for adults with type 1 diabetes to recommend approval in this population.

In a 7-4 vote, the Endocrinologic and Metabolic Drugs Advisory Committee said that Novo Nordisk had not demonstrated that the benefits of its long-acting insulin icodec (proposed brand name Awiqli) outweighed the risks of hypoglycemia for adults with type 1 diabetes. (Though not discussed at the meeting, the product is also under review for adults with type 2 diabetes.)

“The risks are very clear, and the benefits are not,” said Jill Crandall, MD, of Albert Einstein College of Medicine in New York City.

“The fact that we didn’t see any actual benefit demonstrated relative to the comparator in the trial was important to me,” added Erica Brittain, PhD, of the National Institutes of Health in Bethesda, Maryland, who also voted against the product.

Support for a potential indication in adults with type 1 diabetes came from the ONWARDS 6 trial.

In the phase III study, the once-weekly icodec proved non-inferior to once-daily degludec in terms of HbA1c reduction, but from baseline to week 26 the long-acting product was associated with a higher rate of clinically significant or severe hypoglycemia attributed to its peak glucose-lowering effect on days 2 to 4 after injection: 19.9 events per patient-year of exposure as compared with 10.4 events per patient-year with degludec (P<0.0001).

Patient representative Paul Tibbits Jr. said his favorable vote came with “significant struggle.” While he said he thought the once-weekly insulin was approvable for the type 1 population, it would only be after the FDA slapped some “draconian limitations” on it.

If approved, Novo Nordisk’s insulin icodec would be the first basal insulin product for weekly dosing, as all other products on the market are designed for daily dosing.

While the developer made a few suggestions to mitigate the risks of hypoglycemia, many panel members weren’t satisfied and called for even higher safeguards. Some of the proposed mitigation strategies included only using the product with a continuous glucose monitor (CGM), as used in the trial; restricting its use to type 1 diabetes patients whose glycemic variability is less than 36% prior to initiation; only using it in those without a history of hypoglycemia unawareness or recurrence; and only using it in patients after their first year of diabetes onset.

“The patients who may be most likely to benefit from this, in my clinical experience and practice, are unfortunately the ones who tend to be the least likely to actually monitor their blood sugars with some regularity,” said Matthew Drake, MD, PhD, of the Mayo Clinic College of Medicine in Rochester, Minnesota, who also voted against recommending approval.

Representatives of the sponsor on Friday also suggested dosing so the peak glycemic affects take effect over the weekend, when most patients are eating more and have higher blood glucose levels.

But Paul Beringer, PharmD, of the University of South California in Los Angeles, called the proposed risk reduction strategies untested and potentially difficult to implement in practice.

Many panelists agreed that insulin icodec could benefit a subpopulation of patients with type 1 diabetes, but there was no consensus on which population(s) that might be. Some suggested it could be those fearful of needles or those with poor glucose control. Regardless, committee members said it was Novo Nordisk’s responsibility to identify this population, test the weekly agent exclusively on them, and establish safety in another clinical trial.

“It’s not clear that the subpopulation is simply those with low hypoglycemic risk and [those] who use CGM,” argued Robert Greevy, PhD, of Vanderbilt University Medical Center in Nashville, Tennessee. “Notably, those criteria don’t address the key motivation for once-weekly therapy specifically.”

“There should be some work done to identify that subpopulation that we all seem to think is out there,” he added.

Barbara Onumah, MD, of the Diabetes and Endocrine Wellness Center in Largo, Maryland, voted in favor of the weekly product and said she thought there would be a benefit for a subgroup of patients who aren’t able to use once-daily insulin and have suboptimal glycemic control.

While the FDA isn’t required to follow its advisory committees’ recommendations, it typically does.

The US justice department has opened a civil rights investigation into sexual abuse by workers at California’s ladies’s prisons, which have for years been suffering from misconduct scandals.

The department talked about on Wednesday that it became investigating the notify’s two ladies’s prisons – the Central California Ladies folk’s Facility (CCWF) in Chowchilla and the California Institution for Ladies folk (CIW) in Chino – and would evaluate whether or no longer the notify protects incarcerated residents from sexual abuse by correctional workers.

The announcement of the inquiry into the California department of corrections and rehabilitation (CDCR) references the case of Gregory Rodriguez, a long-established guard at CCWF, who’s heading to trial this week on nearly 100 sexual abuse prices, accused of many cases assaulting ladies in his custody for years.

A Guardian investigation last year revealed that the detention center got a narrative of Rodriguez’s abuse in 2014, but as a replace of firing him, punished the sufferer. Court records advised that Rodriguez, 56, went on to commit dozens of extra alleged sexual assaults up till 2022 when he retired while below investigation. He has pleaded no longer responsible.

“No lady incarcerated in a detention center or detention center wishes to be subjected to sexual abuse by detention center workers who are constitutionally crawl to present protection to them,” Kristen Clarke, who leads the justice department’s civil rights division, talked about in a assertion.

“Every lady, in conjunction with those in detention center, retains overall civil and constitutional rights and needs to be handled with dignity and respect. California must be crawl the oldsters it incarcerates are housed in stipulations that defend them from sexual abuse. This investigation will resolve whether or no longer California is assembly its constitutional duties.”

US attorney Phillip Talbert added that concerns about abuse in the ladies’s products and companies had been no longer original. He talked about: “Media protection, notify audits, advocates’ efforts and deepest litigation have sought to procedure consideration to a speak in overall unseen by many in the community.”

Ladies folk have filed an total bunch of complaints in the previous two years alleging abuse by workers at CCWF, the notify’s excellent ladies’s prisons, in conjunction with claims of “injurious groping all the device in which thru searches”, “genital rubbing” and “forcible rape”, the department talked about.

The announcement also important that workers at each and each ladies’s prisons had been accused of coercing ladies into sexual favors in change for contraband and privileges; officers “accountable for dealing with complaints of sexual abuse” have themselves been accused of abuse; and that advocates have documented an “unsafe and inaccessible reporting direction of” the set workers are no longer held responsible.

Ladies folk who came forward last year about Rodriguez and abuse by others described a tool thru which they’ve struggled to access overall products and companies take care of unprejudiced food and hygiene merchandise, and as a consequence had been without complications exploited by guards who offer sources or threaten to elevate them away. They talked about retaliation for speaking out became rampant, in conjunction with being positioned in solitary confinement after reporting abuse.

Records confirmed that women incarcerated in California’s notify prisons filed an total bunch of complaints of sexual abuse by workers from 2014 to 2023, but easiest four officers had been terminated for sexual misconduct all the device in which thru that timeframe. Officers are infrequently ever prosecuted, even when CDCR determines claims of abuse had been substantiated.

Colby Lenz, an recommend with the California Coalition for Ladies folk Prisoners (CCWP), who has long labored with survivors on the 2 institutions, welcomed the investigation on Wednesday: “Here is the becoming circulation to compare what is a crisis in the prisons and what CDCR has no longer taken critically for decades, which has easiest allowed extra folks to be extra sexually assaulted … Here is a virulent illness, pervasive field.”

Declare lawmakers unprejudiced currently passed regulations subsidized by CCWP authorizing the office of the inspector approved to video show and compare claims of workers sexual misconduct against incarcerated folks, a reform meant to take care of the corrections department’s screw ups to retain its beget workers responsible. The bill is now heading to Governor Gavin Newsom’s desk.

A CDCR spokesperson talked about the department had instituted reforms into its investigations of workers sexual abuse so that the cases may possibly well be reviewed by teams at CDCR headquarters, out of doorways of the institution the set the complaint originated. The department has also “intensified workers practising with a center of attention on misconduct” and deployed physique-extinct cameras and expanded surveillance, the spokesperson talked about.

Jeff Macomber, CDCR’s secretary, talked about in a assertion on Wednesday: “Sexual assault is a unsuitable violation of elementary human dignity that isn’t any longer tolerated – below any cases – within California’s notify detention center procedure. Our department embraces transparency, and we fully welcome the US Department of Justice’s neutral investigation.”

Reports have many cases chanced on that sexual abuse by officers is a systemic field in prisons all over the US. The federal bureau of prisons, which falls below the justice department, has been suffering from its beget sexual assault scandals, in conjunction with at its ladies’s facility in California; the US Senate reported in 2022 that workers have sexually abused incarcerated folks in as a minimal two-thirds of all federal ladies’s prisons.