New Delhi: Three pharma companies licensed to manufacture potential Covid-19 drug remdesivir in India are set to receive the Modi government’s approval to conduct the last-stage clinical trial to determine its efficacy.
The proposals submitted in this regard by Indian firms Hetero Labs and Cipla, and US company Mylan, have received a go-ahead from the subject expert committee, which advises apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials for Covid-19.
The three companies received remdesivir parent Gilead Sciences’ nod to manufacture the drug in May. They were among the first to receive a manufacturing licence from the US company, but several others have joined the list since.
The committee’s decision followed detailed deliberations at a meeting on 13 August, according to minutes uploaded on the website of the Central Drugs Standard Control Organisation (CDSCO), the health ministry arm that regulates the quality of drugs and vaccines in the country. The CDSCO is led by the DCGI.
The DCGI will now take a final call on the proposals submitted by the three companies.
Remdesivir is one of the most closely watched treatments for Covid-19. It has been authorised for emergency use among moderate to severe patients but government guidelines bar its use among patients who display signs of liver damage, have severe renal impairment, are pregnant or lactating, or are younger than 12 years.
Last-stage trials refer to Phase 4 or confirmatory trials, and are conducted to find answers to important questions about the effectiveness of the drug.
Committee’s recommendations for Phase IV
The first three phases of a clinical trial estimate the therapeutic efficacy of an experimental drug, and involve an assessment of its risks and adverse reactions before its launched into the market. Phase 4 qualifies as “post-marketing surveillance”. During this phase, data on serious adverse reactions of a drug are noted and reported to the DCGI.
The SEC has laid down certain conditions the three companies will need to follow as they begin the Phase 4 trials.
For one, “in the title of the study the words ‘moderate to severe’ should be mentioned instead of just ‘severe’ to clarify that the treatment should be given to both kinds of patient groups”.
It has also suggested that the trial must note the clearance of “viral load” on Day 7, and Day 14 or during the patient’s discharge from the hospital.
The SEC has also asked drugmakers to add “28 days mortality” as an additional important objective of the study. It means that the companies have to detail how many of the patients who died received remdesivir and how many didn’t.
The companies have also been asked to submit an analysis plan that compares the Phase 4 trial results with “literature data” on remdesivir published so far.
Remdesivir was launched for “emergency use” in India after Gilead Sciences presented data from two global clinical trials — a placebo-controlled Phase 3 study in patients with moderate to severe symptoms of Covid-19, conducted by the US National Institute for Allergy and Infectious Diseases, and the company’s global Phase 3 study evaluating the effects of remdesivir in patients with severe form of the disease.
According to Phase 3 results of the company trial, announced in June, a “five-day treatment course of remdesivir resulted in significantly greater clinical improvement against the treatment with standard of care alone”.
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