Drug Repurposing for Unmet Medical Needs; Request for Information

A medical doctor provides information on the potential for repurposing anti-CD38 drugs, specifically daratumumab and isatuximab, to treat ME/CFS and Long Covid. The commenter highlights successful pilot study results and argues that these drugs are exciting prospects for repurposing due to their efficacy in other conditions and the high prevalence of these chronic diseases.

NCRI Health, a working group at Rutgers University, advocates for identifying ME/CFS, Long Covid, POTS, Lyme-IACCI, and Fibromyalgia as priority disease areas for drug repurposing. They specifically recommend that the FDA expedite the review of low-dose naltrexone for these conditions, citing clinical evidence, real-world data, and a lack of commercial sponsorship for the drug.

An individual is urging the agency to support drug repurposing specifically for the treatment of Long Covid. They argue that the large number of affected people and the lack of currently approved treatments make it an ideal candidate for repurposing.

An individual consumer with Long Covid and a primary immunodeficiency advocates for the FDA to approve Pemgarda as a treatment for Long Covid. The commenter shares their personal experience with the drug's efficacy and urges the FDA to provide full approval and create financial incentives for further research into monoclonal antibody treatments.

The commenter, who was an author on an LCAP committee, advocates for the research and repurposing of antivirals and monoclonal antibodies to treat lymphocytopenia and other symptoms of Long Covid. They provide a personal case study showing how these medications improved their own lymphocyte subsets and request that the agency consider these protocols for long-term therapeutic treatment.

An individual is sharing a personal anecdote regarding the positive effects of the drug PEMGARDA on a loved one's long COVID symptoms. They are requesting that the FDA consider approving PEMGARDA for general use and as a treatment for long COVID.

Matthew Halma, representing the Open Source Medicine Foundation (OSMF), supports the FDA's request for information on drug repurposing and proposes specific priority areas like infection-associated chronic conditions. He offers the organization's open-source tools, infrastructure, and biobank data to help the FDA develop non-commercial, decentralized clinical trial platforms.

The commenter supports the prioritization of off-label use of existing medications to treat long Covid. They argue that the lack of FDA-approved treatments is hampering healthcare providers and that clinical evidence should be used to address the millions of people suffering from the condition.

Biostax Corp (Attune Biotech Inc.) submits a white paper supporting the FDA's initiative to modernize drug repurposing for unmet medical needs. They argue that low-dose naltrexone (LDN) is a prime candidate for this framework because it has established safety, widespread clinical use, and significant federal research support, but lacks a standardized, FDA-approved pharmaceutical product due to market failures.

The commenter advocates for the FDA to consider repurposing the approved drug Mitapivat (Pyrukynd) for the treatment of Long COVID. They argue that the drug's ability to increase ATP production directly addresses the energy metabolism deficits and mitochondrial dysfunction observed in patients with Long COVID and ME/CFS.