Updated October 19th, 2020 at 19:53 IST
AstraZeneca gets approval recommendation for two drugs from EU agency
AstraZeneca, the British pharmaceutical company, lately in news for making COVID-19 vaccine, has earned recommendations by CHMP for approval of two drugs in EU.
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AstraZeneca, the British pharmaceutical company, lately in news for making COVID-19 vaccine, has earned recommendations by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval of two drugs in the European Union. AstraZeneca’s Forxiga and Trixeo Aerosphere, a triple-combination therapy, have been recommended by CHMP for use in the EU.
Read: Thailand Agrees To Manufacture, Supply AstraZeneca's Experimental COVID-19 Vaccine
Forxiga is a drug used for the treatment of symptomatic chronic heart failure in adults with or without type-2 diabetes, while Trixeo Aerosphere is used for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD). Forxiga was approved in the United States in May 2020 under the brand name Farxiga. Meanwhile, Trixeo Aerosphere is sold in the US, Japan, and China under the brand name Breztri Aerosphere.
Read: COVID-19: AstraZeneca Begins Late-stage Trials Of Vaccine With 6,000 Participants
The CHMP recommended Trixeo Aerosphere after studying data from the KRONOS Phase III trial, where both safety and tolerability were consistent. While recommending Forxiga, it stated that the drug is used in adults for the treatment of symptomatic chronic HFrEF. It said that Forxiga is approved in the US as well as in several other countries. It is very likely that the European Commission will approve the drugs because it usually does on the recommendation of CHMP.
Read: COVID-19 Vaccine: AstraZeneca Releases Trial Blueprint, Aims For 50% Effectiveness
AstraZeneca's COVID vaccine development
AstraZeneca recently developed a potential vaccine for COVID-19 in partnership with Oxford University. The World Health Organisation (WHO) called it a frontrunner in the race of COVID-19 vaccine development. The pharmaceutical firm had to stop the clinical trial last month, after some volunteers experienced unspecified illnesses, not sure whether linked to the vaccine or not. The company, however, resumed the trials after a day or so and is continuing in several countries.
Read: US FDA Investigating AstraZeneca's COVID-19 Vaccine Trial, Says Chief
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Published October 19th, 2020 at 19:54 IST
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