The current surge of Covid cases in India continues to strain the country. Over the past week, the country has been reporting over 300,000 new cases per day, and over 200,000 people have died from the disease. The sharply rising case counts are overwhelming hospitals, which face shortages of equipment and supplemental oxygen.
To help contain the crisis, countries, organizations and companies have pledged medical equipment to the country. Others are promising to donate vaccines and the raw materials to manufacture them. But while vaccines may help contain the spread of Covid, they can’t help currently suffering patients. To that end, several pharmaceutical companies are working to expand access to their Covid treatments in India.
On Monday, Gilead Sciences announced that it is donating 450,000 doses of its antiviral drug remdesivir to India, as well as providing support to its local manufacturing partners in India. The company said that it would also work with its generics licensees outside of India to expand capacity to make up for doses produced in India that will no longer be available for export.
Remdesivir is an antiviral drug, and is the only fully FDA-approved treatment for Covid-19 in the U.S. It’s been authorized for emergency use in India and other countries for hospitalized patients. Clinical trials under randomized control conditions in the United States showed that remdesivir reduced time to recovery for patients, reducing hospital stays by several days. A different study, conducted by the World Health Organization, did not show a reduced time to recovery, but that investigation used a less rigorous methodology.
On Tuesday, pharmaceutical giant Merck announced that it has entered into licensing agreements with five generic pharmaceutical manufacturers in India for the production of its antiviral treatment molnupiravir, which the company is developing with Florida-based Ridgeback Biotherapeutics. The drug is currently undergoing a phase 3 clinical trial in the United States, where it is expected to apply for emergency use authorization in September or October. The drug is not yet authorized for use in India, but manufacturing licenses are geared towards making doses available if regulators give it an okay. The company also said it would be donating over $5 million worth of equipment, masks and other supplies to India.
Molnupiravir is an antiviral pill that is aimed at patients who test positive for Covid but are not yet hospitalized. In its phase 2 clinical trial, Merck found that a lower percentage of patients who received the drug were hospitalized or died compared to the control group, and that the amount of virus present in each patient was lower for the group that took the drug.
So far, the best clinical treatments for Covid-19 patients have proven to be antibody therapies. These treatments have been shown to reduce hospitalizations among patients with symptomatic cases of Covid by over 70%, and have also been shown to prevent Covid infections when administered prophylactically. In the United States, both Eli Lilly and Regeneron Pharmaceuticals have received emergency authorization for their antibody cocktails to be administered to Covid patients. Neither has yet been authorized for use in India, however, but both pharmaceutical companies are working on it.
A spokesperson for Roche, which is manufacturing and distributing Regeneon’s antibody cocktail internationally, said in an email that it “is urgently working with local health care authorities to accelerate an emergency use authorisation.” Once that authorization has been received, that “would enable the import of globally manufactured product batches to the country as soon as possible.”
In addition to its antibody cocktail, Lilly has also received authorization from the FDA for administration of its rheumatoid arthritis drug, baricticinib, in combination with remdesivir for hospitalized Covid patients. A spokesperson for the company said in an email that it’s still in discussion with India’s regulators about authorizing its treatments. They went on to say that the company is “in active dialogue with the regulatory authority and government of India to determine if a donation of Lilly’s COVID-19 treatments – including both our neutralizing antibody therapies and baricitinib – would be appropriate to potentially provide relief.”