CMS Decision is an Enormous Setback for Alzheimer’s Patients and a Dangerous Infringement on FDA’s Scientific Autonomy

Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA, says BIO CEO.

Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s Disease:

“The National Coverage Determination released this evening by CMS is an enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making.

“With this decision, CMS is not just saying it has no confidence in Alzheimer’s drugs approved under the FDA’s Accelerated Approval pathway. It also is undermining confidence in FDA’s traditional drug approval process more broadly.

“CMS will now subject these Alzheimer’s drugs approved under the Accelerated Approval pathway to cumbersome, expensive and time-consuming new trials that will delay and limit access. Even access to products approved under the traditional process by FDA will be significantly limited for patients while they wait for a government agreement to set up CMS-approved registries, which history tells us takes years to establish.

“Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA. CMS is chasing innovators out of this critical field and devastating future investment and research going toward treating patients with Alzheimer’s.

“As we have said from the outset, CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30. FDA staffers are scientifically trained at judging the benefit and risk of all kinds of therapies and have a long history of collaboration with the scientific, patient and academic communities. CMS is not equipped to make these judgments, and today’s decision is a dangerous rebuke of the FDA’s hard-earned scientific prowess.

“In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”

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April 17, 2026 - Nutrivert Inc., a developer of non-antibiotic replacements for antibiotic growth promoters in livestock, today announced it has completed the first close, raising $2.375 million, of its Series A-2 funding round of $6 million. The round was led by global animal health investor Arrow Ventures with participation from other investors. The funding will be used to further develop Nutrivert’s manufacturing, human food safety and target animal safety and efficacy packages for the company’s lead product Nutrivert LDPP. Nutrivert LDPP is a proprietary, novel, orally available, lipidated synthetic enantiomeric desmuramyl analog of muramyl dipeptide, the smallest conserved immunoactive component of bacterial peptidoglycan. LDPP has no antibacterial effect but has consistently promoted growth and improved feed efficiency in pig studies. LDPP binds to the mammalian NOD2 receptor and is the only NOD2 ligand reported to inhibit the inflammatory signal NF-κB. In pilot studies, LDPP rescued 70kg pigs from an otherwise lethal dose of porcine reproductive and respiratory syndrome virus (PRRSV) and abrogated influenza disease symptoms in piglets. The Company intends to develop LDPP for all major livestock species worldwide. Patents have been granted in most major markets. The global antibiotic growth promoter market is worth an estimated $5.8 billion. Approximately 73% of all antibiotics are fed to livestock. The market is believed to be the world’s largest drug market by volume, with ~100,000 tons of active pharmaceutical ingredient administered annually. FDA’s latest data, for 2024, show a 13% rise in U.S. livestock antibiotic use since 2017. The Food and Agriculture Organization reports that livestock antibiotics are mostly given to speed animal growth. Regulators and non-governmental organizations have called for reduction of antibiotic use in livestock, citing concerns that the global, intensive use of antibiotics, often at subtherapeutic doses, selects for antimicrobial resistance: bacteria that are “immune” to antibiotics and that therefore pose a threat to public health. Spillovers of antibiotic-resistant bacteria from livestock to humans have been documented. “Nutrivert LDPP has consistently improved feed efficiency in pigs without antibiotics,” said Bernhard Kaltenboeck, CSO. “We are excited to have the support of Arrow Ventures and our other investors in bringing a new tool that will help producers reduce production costs and reduce selection pressure for antimicrobial resistance.” About Nutrivert LDPP: LDPP is an investigational compound currently undergoing clinical evaluation. It has not been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other global regulatory authority for any indication. The safety and efficacy of LDPP have not been established. Any mention of potential use is based on preliminary data and does not guarantee future regulatory clearance or commercial availability.
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