Covid pills may change the way we live with the virus

Health Secretary Sajid Javid called it a “historic day for our country”. For once it cannot be an exaggeration. Beyond Britain, the new drug should serve as a reminder of the importance of antivirals in the fight against this and future pandemics. Friday’s announcement by Pfizer Inc of even better results for its home remedies – an 89% reduction in hospitalizations and deaths in late trials – suggest it won’t be far behind. Pfizer, whose shares jumped on the news, is seeking emergency access authorization in the US

Molnupiravir approval and Pfizer development may not be as timely for UK. The UK has had an extremely high COVID infection rate. While the most recent wave hasn’t resulted in a significant increase in virus deaths, hospitals face a huge backlog of delayed procedures, COVID wards are more than comfortable and there are concerns that a bad flu season will lead to an extreme may affect healthcare. deep crisis.

Even though we have vaccines like dexamethasone and better in-hospital treatments, a safe way to treat COVID at home has been seen as the key to living with the virus. As immunity to vaccines continues to decline, more and more people who have been fully vaccinated are becoming infected with COVID, which can cause infections as well as post-viral diseases. And the risks of long covid are increasing.

Molnupiravir will be prescribed only to people who have at least one risk factor for developing a serious disease, such as obesity, diabetes, or advanced age (over 60). It comes in pill form, which makes it easy to administer at home and, unlike Gilead Science’s remdesivir, the other approved treatment, which is administered intravenously in hospitals for more severe cases.

Rolling out therapeutics has been a priority for the UK government due to pressure on the National Health Service. Back in May, Prime Minister Boris Johnson promised Britain would soon “find a weapon to stop Covid in its tracks.” A new task force, modeled after the highly successful Vaccines Taskforce, was established to identify one-time-use therapeutics that people need. infected.

Last month, the Antiviral Taskforce announced deals for two new treatments. one of 480,000 courses of molanupiravir; The second was for 250,000 courses of Pfizer treatment that included ritonavir (a medicine used to treat HIV infection) along with PF-07321332 (designed to block the work of a key enzyme known to kill the virus). multiplication is required).

These medicines will also prove to be a boon for their makers. Merck, which plans to manufacture 20 million courses in 2022 on top of 10 million this year, has said it expects mollupiravir to reach $7 billion in global revenue by the end of next year (last year’s sales increase). compared to $14 billion in the US for its blockbuster cancer drug Keytruda and $5 billion for its diabetes drug Januvia) — a boon for a company whose marquee products have been hit by the pandemic slowdown in medical screening and care . Pfizer is a bit further behind, hoping to make 180,000 packs of its treatments by the end of this year, but reaching 50 million by the end of 2022. Shares of the company were up 11% in early trading on Friday morning.

If these developments boost the therapeutic industry in general, that would be a good thing. Viruses are difficult to drug because they are constantly changing; Of the 220 viruses known to infect humans, only 10 or so are effective antivirals. Drug discovery for infectious diseases has generally not been a major priority among pharmaceutical companies – surprising since the development cost (easily over $1 billion) and the time it takes to bring a new drug to market (easily a decade) makes them high-risk and potentially low-financial-reward projects.

Antiviral testing requires very high levels of biosafety in facilities, which are expensive to manufacture and significant training. Only a small percentage of drugs that enter clinical trials recover their initial capital investment. Work is often underway for a virus that fades before medical progress can be made, and so the project is shelved. This happened during the 2003 SARS outbreak.

Given the cost and time taken to develop new antivirals, it is no surprise that our best hope for treating COVID-19 comes from drugs that have been dusted off and are now being repurposed. is being used. Molnupiravir was not conceived as a treatment for Covid-19; It was developed at Emory University’s nonprofit Drug Innovation Ventures at Emory (DRIVE) to treat Venezuela’s equine encephalitis virus. The new Pfizer treatment is remodeled from a treatment developed during the SARS crisis.

Several antiviral candidates are now being developed. The pandemic has highlighted the importance of a strategy to support broad-spectrum antivirals as opposed to drugs that try to combat only one virus.

Even in developing countries, treatment can be a big help in the fight against serious illness from COVID-19. Last week, Merck announced that it had signed licensing agreements for broader access to the drug in 105 low- and middle-income countries after receiving regulatory approval. This allows generic versions of the drug to be manufactured, although a lot depends on testing arrangements and distribution channels in these countries as the drug needs to be taken within days of infection.

Like any medicine, it has its risks. While Merck has said it is comfortable the drug would be safe if used as intended, some researchers say more safety data is needed. Of concern, the compound’s “mutagenic” properties (the drug forces the virus to mutate on its own) may harm the host or accelerate the virus’s own ability to develop resistance. Pregnant women were excluded from the trials, and both men and women had to abstain from sex or use contraceptives. It will be interesting to see if the FDA agrees with the MHRA. The US has already purchased 1.7 million courses for $1.2 billion, which breaks down to about $700 for a five-day course. The Pfizer drug, a so-called protease inhibitor that stops the virus from replicating, may be an easy decision.

In the UK and elsewhere that license these new treatments, the delicate balance will be in ensuring that this new line of defense does not undermine booster shots. These are far more effective as they prevent people from getting sick in most cases.

While there is much to celebrate about new treatments and vaccines, a virus that is still claiming a sizable chunk of health care resources and personal costs amid those infected demands has kept the alert.

Therese Raphael is a columnist for Bloomberg Opinion. She was the editorial page editor of the Wall Street Journal Europe.