CHMP Recommends Approval Of Roche’s COVID-19 Antibody Combination
The committee recommends the approval of Roche’s COVID-19 antibody combination based on positive data from Phase 3 trials, which found that the drug reduced risk of death by 20%.
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By - The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of Roche’s COVID-19 antibody combination, Ronapreve.
CHMP recommended the antibody to treat coronavirus in adults and adolescents 12 years of age and older who do not require supplemental oxygen and are at an increased risk of serious disease.
Europe continues to lead the world in percentages of new COVID-19 cases and deaths. According to the World Health Organization (WHO), the number of new cases in Europe rose by seven percent last week and the number of deaths rose by 10 percent.
A final approval decision of Ronapreve, known as REGEN-COV in the US, is anticipated in the near future.
“With cases in Europe surging, it is vital that people have access to different approaches, in addition to vaccines, that reduce the disease burden, and Ronapreve has demonstrated efficacy in treating and preventing COVID-19 and against variants of concern,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the announcement.
“We’re pleased that the committee has now recommended the approval of the antibody combination,” Garraway continued.
Last year, Roche and Regeneron jointly developed REVEN-COV. FDA granted emergency use to the antibody combination in November 2020, and In February 2021, the EMA’s CHMP initiated rolling review.
The agency based its most recent recommendation on positive data from the REGEN-COV 2067 study in non-hospitalized patients and the REGEN-COV 2069 prophylaxis study in people exposed to the virus.
And in June 2021, the drug reduced risk of death by 20 percent in patients hospitalized with COVID-19 who had not mounted their own immune response, compared to standard of care.
Additionally, patients who received the REGEN-COV experienced a 36 percent reduced risk of dying within 29 days of receiving treatment. And patients who were seronegative saw. A 56 percent reduced risk.
Due to the positive Phase 3 trial outcomes, FDA expanded the use of the antibody to include post-exposure prophylaxis in individuals at high risk of severe disease who are not fully vaccinated, who may not mount an adequate response to vaccination, and who have been exposed to the virus or are at high risk of exposure.
