New Delhi: The government could reconsider the inclusion of Tocilizumab in its national treatment protocol after new evidence suggested that the drug did not improve Covid-19 symptoms or reduce deaths.
Tociluzumab is currently a part of the health ministry’s Clinical Management Protocol for Covid-19 under investigational therapies for patients with moderate symptoms. Investigational therapies are those with limited available evidence for “off-label” use and included in the standard protocol after an expert committee approves it.
On 29 July, Swiss pharmaceutical company Roche declared the results of its phase 3 trials of the drug that showed no benefit in improving pneumonia related to Covid-19 or reducing mortality.
Asked whether Tocilizumab will be removed from India’s clinical management protocol, Rajesh Bhushan, secretary, health ministry, said Tuesday: “It is a dynamic situation and if further evidence comes to the committee, they will re-engage on the subject.”
Tocilizumab are monoclonal antibodies that control the inflammatory response of the body when fighting an infection. The drug has been said to be effective in managing the cytokine storm — a harmful overreaction of the immune system.
Tozilizumab is manufactured by Roche under the brand name Actemra and approved for rheumatoid arthritis across the world. Biocon also manufactures Itolizumab under the brand name Alzumab for psoriasis patients.
In July, Director General of Indian Council of Medical Ethics Dr Balram Bhargava had said that both Tocilizumab and Itolizumab have not shown mortality benefits in clinical trials.
Tocilizumab’s results ‘disappointing’
Roche started its phase 3 trials for Tocilizumab under the COVACTA trial in March after it was first considered as a treatment option in China and later in Italy.
Last month, it announced the results of the trials — which were double-blinded, randomised placebo-controlled trials — where Tocilizumab was compared to a placebo and standard care given to hospitalised patients with severe Covid-19 symptoms.
The trial found that the drug did not significantly improve pneumonia associated with Covid-19 or reduce patient mortality. The drug, however, reduced the time spent in the hospital by the patients.
“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, in a statement.
The results are yet to be published in a peer-reviewed journal.
Tocilizumab was earlier priced at Rs 40,500 per vial of 400 mg and sold at inflated price of upto Rs 1.5 lakh. In July, the health ministry had written to DCGI to ensure equitable access to the drug along with Remdesivir, which was priced at Rs 5,500, but sold as high as Rs 60,000 in the black market due to its short supply.
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