Medimmune gets US FDA fast track designation for flu drug

pharmafile | March 9, 2016 | News story | Research and Development  

UK drug major AstraZeneca (LSE: ANZ) said its biologics R&D unit, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its trial-stage human monoclonal antibody (mAb), to treat influenza.

The FDA’s Fast Track programme is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

Steve Projan, senior vice president, R&D and infectious diseases & vaccines iMED Head, MedImmune, said, “We are pleased that the FDA has granted Fast Track designation for MEDI8852 as it recognises the importance of accelerating the development of new medicines for the prevention and treatment of challenging infectious diseases. 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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The human monoclonal antibody (mAb), MEDI8852, is currently in mid-stage trials to test the safety and efficacy of a single intravenous dose in combination with oseltamivir. An early-stage trial showed the drug candidate had an acceptable safety and pharmacokinetics profile.

MedImmune has received Fast Track designation for a majority of its current clinical programmes in infectious disease. In April 2015, the FDA granted fast track status to MEDI8897, a candidate to treat serious respiratory disease caused by respiratory syncytial virus (RSV) in infants. Further, MedImmune’s pneumonia trial drug also received Fast track designation in September 2014.

Anjali Shukla

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