Webinar :Register now for Commodity Ki Paathshala webinar on ‘FPOs & Agriculture Marketing-The Beginning of a New Era’ on January 22, 4pm

Roche's Tocilizumab fails to meet primary end points for COVID-19 associated pneumonia

However, Roche said there was a positive trend in time to hospital discharge in patients treated with Actemra. The median time to discharge or ‘ready to discharge’ for Actemra was 20 days and for placebo was 28 days.

July 29, 2020 / 01:44 PM IST
Representative image

Representative image

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Swiss drug maker Roche on July 29 announced that its drug Actemra (Tocilizumab), which has emerged as a widely prescribed drug for treating hosiptalised COVID-19 patients, didn't meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoint of reduced patient mortality at week four, was also not met.

However, Roche said there was a positive trend in time to hospital discharge in patients treated with Actemra. The median time to discharge or ‘ready to discharge’ for Actemra was 20 days and for placebo was 28 days.

The COVACTA study did not identify any new safety signals for Actemra.

Further analysis of the trial results is needed to fully understand the data.

The results will be submitted for publication in a peer-reviewed journal.

Close

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
Show
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or

mortality at week four," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

"We will continue to generate evidence to provide a more complete

understanding of Actemra/RoActemra in COVID-19 associated pneumonia,”  Garraway added.

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.

COVACTA evaluated the safety and efficacy of intravenous Actemra added to standard-of-care treatment compared to treatment with placebo plus standard of care.

The primary endpoint of clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements.

The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with

study locations in the US, Canada and Europe.

Tocilizumab is anti-IL-6 receptor, that works as immunomodulator, is used in treating patients with autoimmune disorders like rheumatoid arthritis, has found to have some potential to control immune system going berserk in certain COVID-19 patients.

In India, the government protocol says Tocilizumab may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids.

The drug which has to be taken in two doses, is marketed by Roche and its partner Cipla in India.
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: Jul 29, 2020 01:44 pm

stay updated

Get Daily News on your Browser
Sections