Drug reuse may speed up new treatments for Covid-19

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AAs the summer of 2021 began to unfold, many Americans believed the pandemic was starting to wane. But this illusion is over and the country is once again besieged by the coronavirus.

Intensive care units across America are again teeming with Covid-19 patients. Only 55% of Americans are fully immunized, and only 39% at the World level. This paves the way for the emergence of new and deadly variants that will ignore national borders.

These realities clearly show how much we need treatment as well as preventative measures. And we need it as quickly and as cheaply as possible. One way to do this is to invest in the reuse of drugs.

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Although the world is now in need of new treatments, drug development is generally neither fast nor cheap. Granted, the first Covid-19 vaccines were created in less than 12 months, but that time frame was unprecedented and was based on years of underlying research.

On average, it costs around $ 2.6 billion to create a single new drug, and the failure rate is high, with only 12% of investigational drugs moving from the first stage of clinical trials to FDA approval. The average time for a new drug to hit the market is about 10 years.

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This traditional development path is too slow and expensive to cope with an ongoing pandemic.

This is where more than 20,000 pharmaceutical products approved by the FDA in our medicinal arsenal become the key. Some common drugs created for one indication are now used for another. Rogaine’s medicine minoxidil was developed to treat high blood pressure. Ketamine, now approved to treat major depression, was invented decades earlier as an anesthetic. The list goes on.

The reuse of drugs has immense benefits for both developers and consumers. The risks are greatly reduced, as the drugs have not only been tested for safety, but have been widely used. The availability of safety data shortens the approval time. The need for less testing in less time translates into lower development costs.

In fact, recycled drugs cost 50% to 60% less to develop than new drugs and are generally approved between three and 12 years earlier. Since these drugs have already been approved as safe, the FDA gives the green light to around 30% of reused drugs requests for approval, almost three times more than requests for new drugs.

How do companies identify drugs that can potentially be reused? In some cases, they learn that doctors have had success prescribing off-label treatments for a condition other than the one for which the FDA has approved the drug. The practice is surprisingly common, accounting for about one fifth of all prescriptions. It is more common when the conditions are relatively similar, such as using an approved stomach cancer therapy to treat colon cancer. Occasionally, however, the conditions are very different. For example, modafinil is approved to treat sleep disorders, but some doctors have found it to be effective for depression as well.

In other cases, companies are approaching drug reuse by looking at laboratory and clinical trial data on their drugs to see if any of the “side effects” might be of benefit in treating other illnesses. This is what happened with sildenafil, better known as Viagra. It was originally designed as a treatment for cardiac chest pain, but its other attributes, shall we say, have become evident in clinical trials.

Some companies are even doing virtual reuse: analyzing massive amounts of data for links between diseases that, based on symptoms, appear to have nothing in common.

Companies generally still have to submit all normal clinical trial data to get FDA approval on a reused drug. No shortcuts are taken. But the process is faster and cheaper because in many cases at least some of the necessary data already exists – it’s just a matter of repackaging.

The reuse of drugs has already saved many lives during the pandemic. Veklury (the brand name for remdesivir) was originally developed to fight Ebola, but is found to help people with severe Covid-19. FDA approved it for this new use last year. The agency has granted emergency use authorization for Olumiant (baricitinib), first developed to treat rheumatoid arthritis, as a tool against Covid-19.

Hundreds of promising drug reorientation projects are in the process of being approved. Tavalisse (fostamatinib), currently used to treat a bleeding disorder, has shown positive results in the treatment of Covid-19. Phase 2 test data, recently published in Clinical Infectious Diseases, reported that fostamatinib improved outcomes – including mortality, sustainable recovery time and number of days on oxygen – for hospital patients with Covid-19. Phase 3 trials are underway and should be completed by the end of this year.

Meanwhile, studies show that another rheumatoid arthritis medicine, Actemra (tocilizumab), may reduce the death rate of Covid-19.

Raising vaccination rates is a step towards the fight against the coronavirus. But focusing on versatile and already approved treatments could dramatically increase the speed at which we are able to defeat Covid, while also saving money.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest.

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