Indian multinational pharmaceutical and biotechnology company, Cipla Ltd., announced the launch of its generic version of the coronavirus drug, remdesivir, under the brand name Cipremi.
Remdesivir is the only U.S. FDA drug approved for the Emergency Use Authorization treatment for adult and pediatric patients hospitalized with COVID-19. In May, Gilead Sciences, the company that originally manufactures remdesivir, extended a voluntary non-exclusive license to Cipla to mass-produce and retail a generic version of the drug.
According to Cipla, it has been given regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country.
The company said it would conduct training on the use of the drug, handle informed patient consent documents, manage post-market surveillance, and facilitate a Phase 4 clinical trial on Indian patients.
To allow quick and equitable access to treatment and in anticipation of demand, the company will be advertising remdesivir through its own facilities and partnered sites. Cipla added that the medication would be supplied through the government and open market channels to ensure the drug is distributed fairly.
Cipla Ltd MD and Global's CEO, Umang Vohra, said that Cipla is grateful for its strong partnership with Gilead to bring the life-saving drug to India. He says they have been profoundly invested in exploring all possible channels to save lives impacted by the coronavirus pandemic.
Moreover, the company will continue to cooperate with all stakeholders in the healthcare community to provide access to such treatments. Vohra also adds that they believe no patient should be denied access to such transformative therapy.
Remdesivir: Ebola Drug Turned Coronavirus Treatment
Remdesivir was initially used as a drug to treat ebola. However, it did not prove to be successful in its clinical trials. Now, with the COVID-19 pandemic, the antiviral seems to take its shine back for being deemed as the first drug to be approved by the U.S. FDA to treat COVID-19 in emergency cases.
In an interview with The Guardian, Julian Elliott, the lead for Evidence Systems at Cochrane Australia, said that the preliminary data published so far from two clinical trials signify that the drug can reduce the recovery time for patients with the coronavirus infection.
The antiviral drug is administered intravenously and is known as a nucleoside analog, which copies a component of virtual RNA that the virus needs to clone itself. The SARS-CoV-2 uses an enzyme called RNA-dependent RNA polymerase to assemble chains of RNA bit by bit.
When the polymerase grabs the drug instead, the assembly line becomes blocked, thus halting the virus's replication.
What Does Emergency Use Authorization for Remdesivir Mean?
On May 1, the U.S. FDA issued an emergency use authorization for Gilead's remdesivir to be used outside of clinical trials. However, its use is still limited to only those patients hospitalized with severe COVID-19.
Patients who qualify for its emergency use are defined as having an oxygen saturation of less than 94 percent, those who need oxygen supplementation, or those requiring mechanical ventilation or a heart-lung bypass.
Gilead has previously agreed to donate its remaining supply of remdesivir, which was estimated to be a total of 1.5 million doses. They said that about 607,000 doses would be given to the United States and the rest of it across nations around the globe.
