FDA Needs to Stop Saying 'Maybe' on mAbs
It is tempting to think of COVID-19 as an afterthought and relic of the 2020-2021 period. But, to millions of vulnerable Americans with weak immune systems, the disease/virus is still a real and scary prospect. Help is on the way, thanks to a type of monoclonal antibody (mAb) infusion called Pemgarda, which was recently approved by the Food and Drug Administration (FDA) for emergency use authorization (EUA). The infusion is designed to be taken multiple times per year for patients who are not likely to mount an adequate immune response to COVID-19 even after getting their shots. While the FDA should be applauded for their EUA, the agency must do far more to ensure that monoclonal antibody treatments are available for patients who need them the most. Restrictive regulatory policies will fail patients and cost lives in the war against the deadly disease.
Newly available treatments such as Pemgarda will help immunocompromised patients left behind in the “post-pandemic” era. According to Yale Medicine infectious diseases specialist Dr. Scott Roberts, the “population identified as moderately to severely immunocompromised includes solid organ transplant recipients, stem cell transplant recipients, and those who are on chemotherapy for cancers such as lymphoma and leukemia, among many others. This group is also less likely to build enough protection against COVID after vaccination. Hopefully, this new treatment will help the vulnerable feel safer.”
Manufactured proteins such as Pemgarda work wonders by targeting specific viruses or cancer cells and attaching themselves to them. Once these “designer antibodies” are bound to their targets, the virus is neutralized, and the body’s own immune system is flagged to finish the job. The problem is that COVID-19 has constantly changed over the past three years, and older monoclonal antibodies (mAbs) are not as effective in dealing with newer coronavirus variants, not unlike the vaccines.
In response to decreasing effectiveness against some COVID-19 variants, the FDA began revoking authorizations for the six monoclonal antibody treatments it had initially greenlit to treat the deadly disease. In November of 2022, the agency yanked its market authorization for bebtelovimab (designed to treat mild-to-moderate cases of COVID-19), stating the drug was "not expected to neutralize Omicron subvariants” which by then accounted for the majority of infections. Less than two months later, the FDA barred the use of a long-acting antibody therapeutic called Evusheld, effectively eliminating monoclonal antibodies from the market.
The FDA’s recent authorization of Pemgarda seems to mark a regulatory reversal, but unfortunately, doctors, patients, and manufacturers have little insight into the approval process. The FDA’s approval process for these treatments is a black box and requires critical time and resources that patients and innovators do not have. The lack of monoclonal antibody products on the market has created a dire situation for millions of patients with preexisting conditions, who must now risk dangerous drug interactions if they have the misfortune of contracting the coronavirus. While one approved and available drug will undoubtedly improve matters, any supply disruption or significant virus mutations will mean that patients must once again go without COVID-19 treatments.
It does not have to be this way. For example, the FDA currently approves updated versions of the flu vaccine quickly and without the need for expansive clinical trials. All that is typically needed are studies involving 300 adults to ensure effectiveness. The time from identification of new strains to FDA approval is four months, ensuring that patients have reliable access to the latest vaccine version by flu season.
Instead of allowing for quick, flexible trials, the FDA is asking mAb producers for product demand plans, manufacturing scale-up plans, raw materials shortage contingencies “well...in advance” of development. Meanwhile, patient demand is not being met and products are not scaling up because there are so few approved products on the market. It is time for the FDA to reverse course and define a clear process to get life-saving monoclonal antibodies on the market on a continual basis. This will allow our nation to be more proactive in the fight against COVID-19 versus being too slow to react to the quickly changing virus. Millions of lives depend on a faster, more flexible approach.
David Williams is the president of the Taxpayers Protection Alliance.
