Gilead applies for clinical study of coronavirus treatment compound .

Emergency medicine



Gilead applies for clinical study of coronavirus treatment compound

Gilead Sciences said it is working with health authorities in China on a clinical study to see whether a new compound remdesivir can be used to treat novel coronavirus 2019-nCoV.

The Center for Drug Evaluation of the National Medical Products Administration received a clinical trials application from the company over the weekend.

The China-Japan Friendship Hospital also said in an official statement that it would carry out studies in disease-stricken Wuhan for use in clinical treatment.

A source familiar with drug evaluation and approval work told Shanghai Daily that these approvals are only for emergency treatment purposes. Once the epidemic is under control, the new drugs will have to file for new clinical data to be used in treatment for other patients and diseases.

Remdesivir has demonstrated in vitro and in vivo activity against coronaviruses that are structurally similar to 2019-nCoV. It was first developed as a treatment for Ebola virus and Marburg virus infections.

“At the request of treating physicians, and with the support of local regulatory agencies, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options," Gilead said in a statement over the weekend.

According to a paper published in the New England Journal of Medicine last week, the condition of a US patient with 2019-nCoV infection showed improvement after treatment with remdesivir.

Fosun Pharma said its diagnostics division Shanghai Fosun Long March Medical Science Co is also working on expedited approval for its testing kit for 2019-nCoV.

Several kinds of of nucleic acid reagent test kits for the novel coronavirus had been approved by the National Medical Products Administration and received medical device registration certificates at the end of January.