Possible flu therapy fast-tracked by FDA
The U.S. Food and Drug Administration (FDA) has given Fast Track designation to investigational human monoclonal antibody (mAb) MEDI8852, a product of MedImmune, global biologics company AstraZeneca's research and development division.
Fast Track designation is reserved for drugs that can cover an unmet medical need or may be effective in treating more serious illnesses. MEDI8852 currently is the subject of a Phase Ib/IIa clinical trial, which will assess its safety and effectiveness. It is an IV drug to be used in combination with oseltamivir.
“We are pleased that the FDA has granted Fast Track designation for MEDI8852, as it recognizes the importance of accelerating the development of new medicines for the prevention and treatment of challenging infectious diseases,” Steve Projan, MedImmune senior vice president of research and development, said. “This is the fourth such designation that MedImmune has received for potential medicines in infectious diseases since 2014, a testament to our commitment to meeting unmet medical need.”
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