Moneycontrol PRO
Upcoming Event:Attend Algo Convention Live, 2 Days & 12+ Speakers at best offer Rs.999/-, exclusive for Moneycontrol Pro subscribers. Register now!
you are here: HomeNewsBusiness

Dr Reddy's terminates Kuwait clinical trial of favipiravir on moderate to severe COVID-19 patients

The data from the Kuwait study involving moderate-severe COVID-19 hospitalized patients did not show statistically significant difference for the primary endpoint or the time taken to resolve hypoxia. However, low risk category COVID-19 patients on the broad spectrum antiviral got discharged three days ahead of the placebo group.

January 27, 2021 / 06:56 PM IST
Representative image

Representative image

  • bselive
  • nselive
Todays L/H

Dr Reddy’s Laboratories and Global Response Aid (GRA) on January 27 announced the termination of Avigan (favipiravir) clinical trial conducted in Kuwait on moderate to severe COVID-19 patients in a hospital setting, as the data failed to show a statistically significant difference for the primary endpoint.

The data from the Kuwait study involving moderate-severe COVID-19 hospitalised patients did not show a statistically significant difference for the primary endpoint or the time taken to resolve hypoxia. However, low-risk category COVID-19 patients on the broad spectrum antiviral got discharged three days ahead of the placebo group.

GRA is an alliance focused on improving medical supply chain worldwide. Hypoxia is a condition in which the body is deprived of adequate oxygen supply. Hypoxia is the major symptom in patients with moderate-severe COVID-19.

While it took seven days or a day less than placebo for resolution of hypoxia in the Avigan arm.

Dr Reddy's said the full data analysis on 353 subjects would be available by the end of February 2021.


COVID-19 Vaccine

Frequently Asked Questions

View more
How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

View more

The drugmaker said a sub-group analysis carried out on 181 subjects in the low-risk category had shown patients on Avigan getting discharged three days ahead of the placebo group.

"The sub-group analysis of the low-risk study cohort (n=181) demonstrated a 3 day earlier discharge in Avigan group compared to a placebo group (8 days vs 11 days; p=0.0063) for time to hospital discharge secondary endpoint," Dr Reddy's said in a statement.

"The subgroup analysis data during the initial interim analysis points towards the hypothesis with clinically significant insights from this study that an antiviral drug like Avigan may be effective as part of early treatment initiation in COVID 19 patients and not effective in the late-stage hospital treatment for moderate and severe COVID 19 patients," Dr Reddy's added.

The hospitalised patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of asymptomatic to severe cases of COVID-19 in both outpatient and in-patient setting.

Dr Reddy's said the Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America in partnership with Appili Therapuetics and Global Response Aid, will continue.

Dr Reddy's last year entered into a three-way deal with Japanese drugmaker Fujifilm and Dubai-based Global Response Aid to manufacture and sell its flu drug Avigan (favipiravir) for the potential treatment of COVID-19,

Favipiravir was approved in India for restricted emergency use on patients with low to moderate COVID-19. Dr Reddy's along with over dozen companies have launched are selling the drug in India.

Download your money calendar for 2022-23 here and keep your dates with your moneybox, investments, taxes

Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jan 27, 2021 06:56 pm
ISO 27001 - BSI Assurance Mark