Gilead's Remdesivir Receives Special Approval in Japan for COVID-19 Treatment

On May 7, 2020 (U.S. time), Gilead Sciences announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) had approved Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection—the virus responsible for coronavirus disease 2019 (COVID-19)—through its special approval pathway. The special approval was granted in response to the COVID-19 pandemic and referenced the Emergency Use Authorization (EUA) for remdesivir in the United States.

This approval is based on existing data from the National Institute of Allergy and Infectious Diseases (NIAID) global Phase 3 trial, Gilead’s SIMPLE Phase 3 study in patients with severe COVID-19, and Gilead’s compassionate-use program, which included patients from Japan.

“Japan’s approval of remdesivir was based on the urgent need to treat critically ill patients in Japan. This reflects the exceptional circumstances of the current pandemic,” said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences. “We thank the Japanese Ministry of Health, Labour and Welfare for its leadership and collaboration in addressing this public health emergency.”

Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for remdesivir for the treatment of novel coronavirus pneumonia. In the United States, remdesivir is an investigational drug that has not been approved by the FDA for any use, and its safety and efficacy for the treatment of novel coronavirus pneumonia have not been established. In the United States, remdesivir is authorized only for the treatment of hospitalized patients with severe novel coronavirus pneumonia.

Remdesivir has not yet been licensed or approved in countries outside of Japan, and ongoing clinical trials continue to evaluate its safety and efficacy. Gilead Sciences continues to collaborate with global regulatory authorities to ensure appropriate access to remdesivir.

Meanwhile, Gilead Sciences issued a statement on the global supply of its investigational antiviral drug remdesivir.

The statement pointed out that since January, Gilead has been carrying out rapid, cautious, and diligent work to prepare for the potential effectiveness of its investigational antiviral drug remdesivir against novel coronavirus pneumonia. The results of recent clinical trials and the decision by the U.S. Food and Drug Administration (FDA) to grant an Emergency Use Authorization (EUA) for remdesivir highlight the urgency of this effort and the importance of planning for global accessibility to remdesivir.

Gilead’s primary objective is to ensure that remdesivir is accessible and affordable for governments and patients in various countries following regulatory approval. In light of the urgent global demand from patients, the company is implementing the following strategies to further advance and maximize the accessibility of remdesivir.

Under voluntary licensing arrangements, Gilead Sciences is discussing production capabilities with several leading global chemical and pharmaceutical manufacturers to produce remdesivir for Europe, Asia, and developing countries through at least 2022. The company is also negotiating long-term voluntary licenses with several generic drug manufacturers in India and Pakistan to produce remdesivir for developing countries. Gilead will provide appropriate technology transfer to facilitate such production. Furthermore, Gilead is actively exploring licensing options for remdesivir in developing countries through the Medicines Patent Pool, a partner of many years.

The statement further indicated that, to further advance the accessibility of medicines in developing countries during this severe health crisis, Gilead Sciences is engaged in in-depth discussions with the United Nations Children’s Fund (UNICEF) to provide remdesivir by leveraging UNICEF’s extensive experience in delivering medicines to low- and middle-income countries during emergencies and humanitarian crises, as well as its robust distribution network.

Responsible Editor: Sanqi

Disclaimer: This article is reproduced from Yaozhi.com. The copyright belongs to the original author. The purpose of this reproduction is to convey more information, which does not represent the views of this platform. If there are any issues regarding the content, copyright, or other matters, please leave a message on our website, and we will remove the content promptly.