Gilead's Remdesivir Receives CHMP Positive Opinion for Conditional Approval in EU as First COVID-19 Treatment
Gilead Sciences
Antiviral Drug Developer
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
On June 25, the EU CHMP recommended conditional approval for the marketing of Gilead’s Veklury (remdesivir) for the treatment of severe COVID-19 in patients aged 12 years and older. This marks the first COVID-19 therapeutic recommended for approval in the EU.
Remdesivir has currently received Emergency Use Authorization from the FDA and formal approval in Japan. Clinical trials of remdesivir in combination with other therapies are currently underway, and the FDA has also approved the initiation of clinical trials for its inhalable formulation. The inhalable formulation will be administered via a nebulizer, enabling easier administration for patients in the early stages of the disease and outside of hospital settings.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.
