Comment from Anonymous

INTRODUCTION I am submitting this comment in response to FDA Docket No. FDA-2026-N-4492, “Drug Repurposing for Unmet Medical Needs.” I am writing about the use of the drug Pemgarda (Pemivibart) to treat Long Covid (Post-Acute Covid Syndrome.) I am an individual consumer whose Long Covid symptoms have improved dramatically as a result of taking Pemgarda. Long Covid patients are in desperate need of more medical options. The Department of Health and Human Services estimates that Long Covid affects 5-7% of adults in the US, or about 18 million people. (Source: https://www.hhs.gov/longcovid/index.html) Yet there are currently no FDA-approved treatments for Long Covid. Pemgarda should be the first. Pemgarda is currently a drug with EUA approval for the pre-exposure prophylaxis (prevention) of acute covid in immunocompromised adults who have inadequate responses to covid vaccines. (More info: https://pemgarda.com/hcp/ ) Pemgarda has been highly effective at preventing acute covid infection in immunocompromised adults, and should absolutely receive full FDA approval for that purpose. But in addition, it should also be repurposed for Long Covid. BACKGROUND: I am an adult with a primary immunodeficiency. Despite being vaccinated for covid, I am at risk of death or serious harm to my health from any covid infection. Between 2021-2024, I was infected with covid 6 times, in spite of taking great precautions and making personal sacrifices to avoid infection. I was vaccinated & boosted at the time of all of my six covid infections. Every covid infection caused long-term health damage, which appeared, at the time, to be permanent. I lost the ability to work full-time. I developed difficulty breathing while doing everyday activities. I developed new pain: muscle pain, paresthesias that felt like my skin was on fire all the time, daily headaches. I was constantly exhausted, to the point of being bedridden. My hair started falling out. Long Covid was destructive to my health. For years, I tried to find a treatment for my Long Covid but nothing worked. I kept getting worse with each reinfection. When Pemgarda was approved for its EUA, I qualified to get Pemgarda as an immunocompromised adult. I started taking Pemgarda in October 2025 and the results were extraordinary. First of all, I stopped getting re-infected with covid, which is Pemgarda’s main purpose. The drug is fulfilling its FDA-approved purpose. (And it should be granted full approval for that.) But what surprised me was, it also improved my Long Covid symptoms! My burning skin parasthesias stopped within 30 minutes of receiving my first Pemgarda infection and never came back. My muscles felt better: less painful, less spastic, more energetic. My lungs felt better. My headaches stopped. I had more energy. I could work full-time again. My hair stopped falling out. I became active again. All of these improvements began to happen rapidly after I started taking Pemgarda. Every time I get another infusion, I feel better and better, getting closer to my “pre-covid” self. ANALYSIS: Approving Pemgarda as a Long Covid treatment would positively impact millions of people. I got lucky; I happened to qualify for Pemgarda under the EUA for immunocompromised adults. But most Long Covid patients don’t fit the narrow EUA criteria, and they need access to an FDA-approved treatment. As a positive side effect, approving Pemgarda for Long Covid would improve public health. Many Long Covid patients are at high risk of re-infection, either because 1) they have a pre-existing medical condition that makes them susceptible to Long Covid, or 2) they live, work, or get healthcare in an environment that makes them likely to experience lots of covid exposures. RECOMMENDATIONS: 1. Approve Pemgarda for use in treating Long Covid patients, to support the unmet medical needs of these 18 million (or more) Americans. 2. Since Pemgarda currently only has an EUA approval for use in immunocompromised adults, grant it full approval to ensure that immunocompromised adults have continued access. It is highly effective for preventing acute covid infections in immunocompromised adults. 3. Create financial incentives for drug companies to research and develop treatments for Long Covid using monoclonal antibodies (like Pemgarda does). CONCLUSION: Long Covid patients have urgent unmet medical needs. There are currently no FDA-approved treatments for the 18 million American adults with Long Covid. Pemgarda’s long-acting monoclonal antibodies have shown incredibly positive effects on Long Covid patients. Pemgarda should be the first FDA approved treatment for Long Covid patients. Also, the FDA should support the development of similar drugs.