Shots:

• The approval is based on 4 P-III studies i.e., (COVACTA), (EMPACTA), (REMDACTA), & (RECOVERY) evaluates the safety & efficacy of Actemra/RoActemra (IV) in ~5,500 patients with COVID-19 who receive systemic corticosteroids & require supplemental oxygen or mechanical ventilation
• The EC’s decision follows an accelerated assessment by the EMA’s CHMP. Additionally, the company is working closely with regulatory bodies & others globally to bring the therapies for patients imminently
• Actemra/RoActemra is 1st approved anti-IL-6 receptor biologic which is available in IV & SC formulations for RA & also approved in Australia. The therapy was authorized for emergency use in the US & Ghana

 Ref: Globe Newswire | Image: Roche