The regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for "restricted emergency use" to treat COVID-19 patients with moderate to severe acute respiratory distress, officials told PTI on Friday.
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Considering the unmet medical needs to treat COVID-19, Drugs Controller General of India, Dr. V G Somani, approved monoclonal antibody injection Itolizumab, an already approved drug of Biocon, for restricted emergency use for the treatment of 'cytokine' release syndrome in moderate to severe acute respiratory distress syndrome patients due to COVID-19, they said.
"The approval was given after its clinical trials on COVID-19 patients in India was found satisfactory by the expert committee comprising pulmonologists, pharmacologists, and medical experts from AIIMS, among others, for treatment of cytokine release syndrome," an official told PTI.
"It is already an approved drug of Biocon for treating psoriasis for the last many years," the official said.
Written informed consent of each patient is required before the use of this drug, he said.
The other drugs helping to cure Covid-19 patients
Indian pharma companies launched three drugs for the emergency care of Covid-19 patients. Here’s all you want to know about Fabiflu, Cipremi, and Covifor.
Fabiflu
- The drug will be used for the treatment of mild to moderate COVID-19 patients
- The medicine will be in oral form
- Favipiravir can be used in COVID-19 patients with co-morbid
- conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms.
- According to a statement by the company the drug can cause a rapid reduction in viral load within 4 days. It has also shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.
- The drug will be available as a prescription-based medication.
- It will cost Rs 103 per tablet
- The company statement said that the recommended dose is 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14
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Cipremi
- According to a statement by the Mumbai based company Cipla, the anti-viral drug Remdesivir demonstrated faster time to clinical recovery in hospitalized patients as compared to placebo in 1063 patients over 60 centres across U.S., Europe, and Asia.
- Cipremi will be available as Remdesivir lyophilised powder for injection 100 mg
- It will be available through Government and open market channels
- Pricing of the drug has still not been disclosed by the company
- It will also be available for restricted emergency use
Covifor
- Hyderabad-based pharma company Hetero has also launched Remdesivir
- The company will be supplying Remdesivir in 127 countries, including India
- According to a statement by the company ‘under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of the disease. The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process
- Media reports say that the drug will be for Rs 5,000-6,000 for a 100-mg dose