Researchers race to get new, repurposed drugs approved

On average, it takes a decade to develop a new drug, experts say

NEW DELHI : Researchers are racing to get approval for new and repurposed drugs and treatments that protect against severe forms of coronavirus disease (Covid-19) with no hope for a vaccine before 2021.

Infusing the antibody-rich blood plasma of people who have recovered from Covid-19 was approved for use as a treatment for critically ill patients in the US on Wednesday.

Two New York city hospitals, Mount Sinai and Albert Einstein College of Medicine plan to start plasma — the liquid component of the blood that contains antibodies — therapy early next week, even as three protocols for clinical trials were submitted for approval to the US Food and Drug Administration.

Most recently used in China to treat Covid-19 patients, plasma or antibody therapy has been used to treat infections since the 1890s. A Lancet report said that during the Spanish Flu pandemic in 1918, it lowered death rates by 21%, according to a meta-analysis of eight studies involving 1,703 patients from 1918-1925.

In China, seven of 10 patients given antibody therapy recovered, according to preliminary findings published in medRxiv, the preprint server for health sciences. The results of several other studies from China on this are yet to come. “It has been used against other viral infections with varying success. It lowered viral load and deaths in people with severe acute respiratory infections during the H1N1 pandemic of 2009-10, and improved survival in patients with severe acute respiratory syndrome (SARS),” said Dr G C Khilnani, chairman of PSRI Institute of Pulmonary and Critical Care in New Delhi, and former head of pulmonology at AIIMS, New Delhi. The WHO has recommended its use against Ebola during outbreaks, and issued protocols for its use to treat Middle East respiratory syndrome (Mers).

India, and the rest of the world, has fast-tracked approvals of repurposed drugs and therapies to lower severe disease and death till a vaccine is available. “The goal is to speedily take research to implementation by facilitating collaborations for new tests and diagnostics, repurposing drugs approved for other purposes, and testing for effectiveness against Sars-CoV-2,” said K VijayRaghavan, principal scientific advisor to the government and co-chair of Empowered Committee for Covid-19 Response.

On average, it takes a decade to develop a new drug, with only one in five experimental molecules to treat infectious disease reaching the clinical trials stage, according to data from the Biotechnology Innovation Organization, the world’s largest biotech trade association.

India this week approved the use of anti-malarial drug hydroxychloroquine in treatments against Covid-19, to protect people at high risk of infection and banned the export of the finished drug and its component ingredients . “The Indian Council of Medical Research approved hydroxychloroquine as a prophylaxis for people at high-risk... I have to caution that it is not a prophylaxis for the general population and must not be used as such,” said Dr Khilnani, who is also a member of Delhi government’s committee on Covid-19 response.

India has so far approved the combination of two antiviral drugs used to treat HIV, lopinavir and ritonavir (400 mg and 100 mg, respectively) to treat Covid-19. The first major study of Covid-19 treatments found it did not work on severely ill patients in China, according to a trial in China published in The New England Journal of Medicine on Wednesday.

The experimental antiretroviral remdesivir, which failed as an Ebola treatment, successfully prevented disease in rhesus macaques infected with Middle East respiratory syndrome coronavirus (Mers-CoV), according to a new study by scientists at the US National Institutes of Health. Six large studies are in progress, with the first, in severely ill patients in China, due next month.

A repurposed commonly-used clot-busting drug may also work as an emergency measure for Covid-19 patients suffering from acute respiratory distress when ventilators are unavailable or ineffective, according to researchers at the Massachusetts Institute of Technology and the University of Colorado at Denver, Colorado. Emerging data from China and Italy showed that Covid-19 patients have severe blood-clotting disorders that lead to respiratory failure and death.

The clot-buster is made from a protein called tissue plasminogen activator (tPA) that is given intravenously to people after a cardiac arrest or stroke to dissolve blood clots, and is easily available across India.