India's drug regulator grants Gilead Sciences marketing authorisation for remdesivir

New Delhi: India's drug regulator has granted US pharma giant Gilead Sciences marketing authorisation for its anti-viral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients in view of the crisis posed by the pandemic.

The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak, a source in the know of the developments told .

The drug has been allowed for restricted emergency use for a maximum of five-day period for treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalised with severe symptoms, subject to several safeguards, the source said.

"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional set-up only. It has been approved for use for a maximum of five days as against 10 days. Extended use does not seen to have any beneficial effects based on the evidence submitted at the time of approval," the source told .

"The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances," the source said.

Gilead Sciences had on May 29 applied for marketing authorisation for remdesivir in India. The drug is being touted as a potential treatment for COVID-19.

The approval was given following consultation with the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO).

"The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting," the source said.

The drug, from the Gilead's manufacturing site, would be imported by Mumbai-based Klinera Global Services, the sources said.

Gilead Sciences, the patent holder of the drug, has the complete data about the pre-clinical and clinical studies for remdesivir.

The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19, they said.

Meanwhile, applications of two Indian pharmaceutical companies -- Cipla and Hetero Labs -- seeking permission to manufacture and sell remdesivir in India is still under consideration.

Gilead Sciences Inc has entered into non-exclusive licensing agreements with pharma firms, including three domestic majors Cipla, Jubilant Life Sciences and Hetero, for manufacture and distribution of remdesivir.

The Indian Council of Medical Research had earlier said anti-viral medication remdesivir, which was used during the Ebola outbreak, may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of COVID-19 is a part of the WHO's 'Solidarity Trial'.

According to a recently published study in the New England Journal of Medicine, two out of three critically ill coronavirus patients who were on oxygen support showed signs of improvement when they were administered remdesivir.

All new drugs have to undergo trials before getting approval for marketing them in India.

However, the New Drug and Clinical Trial Rules, 2019, provide for certain clauses, according to which the provision of waiver of local phase-III clinical trials of the drug is approved and marketed in certain countries (as notified from time to time) subject to certain conditions like national emergency or epidemics in public interest.

Gilead Sciences issued a statement on Remdesivir Clinical Data on Monday, saying, "With the latest data announced today, we now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures."

Results from the Phase 3 SIMPLE trial showed that when treating patients with moderate disease - those with pneumonia who do not require supplemental oxygen - a 5-day course of remdesivir led to greater clinical improvement than standard care alone, the company said.

Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

The placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases demonstrated that remdesivir enabled more rapid recovery and that earlier treatment improved outcomes in patients with a range of disease severity.

An earlier study results showed that when treating patients with severe disease - those who require non-invasive supplemental oxygen - 5 days of remdesivir led to similar improvements as a 10-day course.

"The totality of clinical data shows that remdesivir has the potential to meaningfully benefit patients with COVID-19 and offers important hope," it said.