07 March 2016
AstraZeneca today announced that its global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain 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.
MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supported continued development in patients with influenza.
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.”
MedImmune has received Fast Track designation for the majority of its current clinical programmes in Infectious Disease. In April 2015, the FDA granted fast track status to MEDI8897, a novel monoclonal antibody for the prevention of serious respiratory disease caused by respiratory syncytial virus (RSV) in infants. Fast track designation was also granted in September 2014 to MEDI3902, for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious disease in hospitalised patients. In late 2014, MEDI4893 was granted fast track status for the prevention of pneumonia caused by the bacterium Staphylococcus aureus (S. aureus) in intensive care unit patients, which is also often multidrug resistant.
NOTES TO EDITORS
MEDI8852 is an investigational human IgG1 kappa monoclonal antibody (mAb) administered via infusion. The precursor to MEDI8852 was isolated from human memory B cells by Humabs BioMed, and further optimized for enhanced neutralization activity at MedImmune. MEDI8852 binds to a region within the stalk of the hemagglutinin protein that is highly conserved amongst all influenza A subtypes. MEDI8852 is being developed as a treatment for patients hospitalized with influenza caused by Type A strains in conjunction with local standard of care. While MEDI8852 is being developed as a treatment for seasonal influenza disease, it is anticipated that it could also be used in the pandemic setting.
Influenza virus infection remains a serious threat to global health and world economy. Annual epidemics result in a substantial number of hospitalizations, with an estimated 3-5 million cases of severe disease and 250,000-500,000 deaths globally, and higher mortality rates are possible during pandemics. Given the emergence of drug-resistance, the short treatment window of antivirals and the lack of universal or broadly cross-protective vaccines, there is a significant unmet medical need for new therapeutic agents that can effectively treat influenza infection.
MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
|Neil Burrows||UK/Global||+44 20 7604 8032|
|Vanessa Rhodes||UK/Global||+44 20 7604 8037|
|Karen Birmingham||UK/Global||+44 20 7604 8120|
|Jacob Lund||Sweden||+46 8 553 260 20|
|Michele Meixell||US||+1 302 885 2677|
|Thomas Kudsk Larsen||+44 7818 524185|
|Eugenia Litz||RIA||+44 7884 735627|
|Nick Stone||CVMD||+44 7717 618834|
|Craig Marks||Finance||+44 7881 615764|
|Christer Gruvris||Consensus Forecasts||+44 7827 836825|
|Lindsey Trickett||Oncology, ING||+1 240 543 7970|
|Mitch Chan||Oncology||+1 240 477 3771|
|Dial / Toll-Free||+1 866 381 7277|
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal