Shah, whose company developed the oral testosterone drug Kyzatrex, urged regulators to broaden treatment access and align policy with modern science and preventive healthcare goals.
By AB Wire
WASHINGTON, DC: Marius Pharmaceuticals CEO Shalin Shah joined a dozen other experts on the landmark “Expert Panel on Testosterone Therapy for Men,” convened by the U.S. Food and Drug Administration on Wednesday, to make a scientific case for expanding access to testosterone therapy.
The session was one of several panels the FDA has introduced this year to gather input from medical experts through roundtable discussions that frequently offer insight into possible future regulatory actions.
FDA Commissioner Marty Makary, speaking on the panel, told the panelists that the agency wants to learn more about this topic, without any pre-conceived notions.
Dr. Brian Christine, Assistant Secretary for Health at the Department of Health and Human Services (HHS), described the panel as a significant step forward for men’s health. He noted that conversations about men’s hormones have “for too long remained in the shadows,” and said that discussions like this one mark a turning point in bringing greater attention to the issue.
Besides Shah, the panelists included Dr. Landon Trost, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah; Dr. Helen Bernie, associate professor of urology at the Indiana University School of Medicine; and Dr. John Mulhall, urologic surgeon at Memorial Sloan Kettering Cancer Center in New York.
Shah urged federal agencies to modernize outdated medical and regulatory frameworks that, in his words, are keeping millions of men from receiving care for a condition that quietly worsens their health.
“The FDA, with its global leadership on healthcare standards, has the opportunity to drive a framework that can impact half a billion men and women globally who need testosterone and hormone therapy,” Shah said.
At the center of the discussion was Testosterone Replacement Therapy (TRT), a treatment for men whose bodies do not produce enough of the hormone. The panel, which included some of the nation’s leading urologists and health officials, strongly advocated for expanding access to TRT.
Low testosterone level can contribute to a range of health problems and significantly affect a man’s physical, emotional, and mental well-being. Its symptoms include decreased libido, fatigue, mood changes, and loss of muscle mass.
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In March 2015, the FDA ordered major label changes for testosterone products, adding warnings about possible increased risks of heart attack and stroke and limiting approved use to men with confirmed hypogonadism — a condition characterized by low testosterone levels.
Shah praised the FDA for re-examining the science around testosterone deficiency. He argued that current labeling and access barriers are rooted in outdated fears rather than medical evidence.
“Testosterone deficiency is a disease amplifier,” Shah said. “There is an androgen receptor on nearly every organ in our body, and our body should not be devoid of this critical hormone.”
He pointed out that prior to the 2015 label change, “clinicians could treat testosterone deficiency without having to specifically identify, similar to most major diseases we treat today. If a patient has high blood pressure, we treat it.”
“High A1C, we treat it. Low vitamin D — a hormone — we treat it,” he said. “There’s no medical or scientific reason to treat testosterone deficiency any differently, especially when we know it increases all-cause mortality. This is not a lifestyle drug.”
The past few years have seen major breakthroughs in testosterone therapy, bringing renewed optimism to millions of men suffering from low testosterone.
The Raleigh, N.C.,-based Marius, founded by Indian American entrepreneur and investor Himanshu Shah, introduced to the market the testosterone drug Kyzatrex, an oral prescription drug tailored to treat adult men grappling with low or nonexistent testosterone levels due to specific medical conditions.
Shah and other panelists emphasized that TRT has been underused in recent years because of lingering, outdated concerns linking it to prostate cancer, stroke, and heart disease.
Shah framed testosterone not as an enhancement therapy but as a preventive tool, a hormone vital to multiple bodily functions and a potential weapon against chronic disease. “To better help clinicians and patients drive health outcomes, the agency can accelerate an approval of a broader umbrella indication demonstrating testosterone deficiency as an adjunct to comorbid metabolic disease,” he said. “There is significant data and recognized mechanisms to make this shift.”
Shah tied his remarks to a contemporary medical phenomenon: the surge in the use of GLP-1 drugs such as Ozempic and Wegovy. He warned that while those medications help millions lose weight, they also cause rapid muscle loss — a development he views as an urgent signal for regulators.
“A massive case study is actually unfolding before our eyes. Close to 20% of American adults have tried or are on GLP-1 drugs. Shockingly, 40% of this weight loss that occurs is lean muscle.”
Contrasting the multibillion-dollar pursuit of new drugs with the underutilization of existing hormonal therapies, Shah said: “While Big Pharma spends tens of billions of dollars on experimental treatments with unknown side effects, we have a simple solution right in front of us — testosterone.”
He said that testosterone should not be viewed as experimental, cosmetic, or niche. Instead, he called on the FDA to act decisively. “We need to fast-track an approval to use testosterone alongside GLP-1s in order to prevent a frailty crisis.”
Shah also took aim at the healthcare system’s structural failures — from insurance barriers to regulatory inconsistencies — that, in his view, keep patients from receiving preventive care.
“When Marius launched Kyzatrex, we actually launched it as a cash-only model with a direct-to-patient core philosophy, and we did this because our traditional medical system wasn’t built for access or preventive care,” he said. “If we care about future health, we cannot let clinical care be dictated by insurance companies. We need the support of the government to help drive a better framework for these decisions.”
The Marius CEO said that framework should begin with testing and coverage. “The first part of this framework is testing. Most men struggle with their doctors to get a simple testosterone level done. And while there’s a good case for screening all men, we should certainly be screening men with any metabolic dysfunction, including depression,” he told the panel.
He urged the U.S. Preventive Services Task Force to make testosterone screening a mandatory, covered benefit, especially for at-risk men.
“The U.S. Preventive Task Force should implement mandatory coverage to support this framework. The other part of this access framework is treatment — again, a concept that cannot be left to payers and PBMs.”
Shah called for Medicare and commercial insurers to provide equal coverage for all testosterone formulations, including oral therapies such as Kyzatrex. “Starting with a national coverage determination from Medicare, which all commercial insurers should follow, coverage of all testosterone formulations should be equal and agnostic so patients and providers can make the best clinical choices for that individual.”
He proposed that the Department of Health and Human Services consider testosterone therapy an essential health benefit—a move that, he said, would reduce access barriers for millions. He also noted that Marius Pharmaceuticals has pledged to continue a “most-favored-nation policy” to support government efforts to make the therapy affordable.
Perhaps his most pointed criticism came when he discussed testosterone’s legal classification. “Descheduling also plays a critical role in this access equation. Testosterone has lower abuse potential than caffeine, yet is regulated more tightly than cannabis in half of this country today.”
Beyond the medical and regulatory arguments, Shah made a financial case. He cited data from the Department of Veterans Affairs, which showed significant reductions in mortality and cardiovascular events among men treated for low testosterone.
“In the VA, normalization of testosterone in over 80,000 hypogonadal men was associated with a 56% lower all-cause mortality and meaningful reductions in heart attacks and strokes.”
According to Shah, scaling that result nationally could yield major savings. “If you apply these reductions to 1,000,000 high-risk men, you’re talking on the order of $5 billion in MI and stroke costs alone that can be saved.”
He continued, “Medicare is now covering 30 million men, and the best data estimates at least 10 million of these men are hypogonadal — many with diabetes, heart disease, and elevated cancer risk. If we simply identify, through testing, and treat about half of these high-risk men with physiologic testosterone using the same risk reductions we’ve already seen in VA cohorts, T4DM, and the Lopez cancer study, a conservative model suggests on the order of $16 billion in Medicare savings over five years.”
To Shah, the argument is about much more than economics. It’s about redefining how the healthcare system approaches prevention and male health. “This doesn’t count frailty, falls, dementia, productivity, and other benefits. The point is: for Medicare and our healthcare system, low testosterone is not a cosmetic issue — it’s a multibillion-dollar preventive care opportunity.”