FDA Grants AstraZeneca MEDI8897 Breakthrough Treatment Designation
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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, pharmaceutical(http://giant AstraZeneca announced that the u.SFood andDrug(http://Administration (
FDA(http://) has granted MEDI8897 breakthrough treatment designation (BTD)In March 2015, MEDI8897 was also granted fast-track eligibility by the FDAThe FDA granted MEDI8897 BTD, a preliminaryanalysis(http://results based on a phase IIb clinical study evaluating the efficacy and safety of MEDI8897data show that the study reached its main endpoint, defined as a statistically significant reduction in the incidence of RSV-induced MEDICAL care LRTI in RSV within 150 days of administration in's Health(http://premature babiesThe full results of the study will be presented at the upcoming medicalconference(http://MEDI8897 is being developed for a wider infant population than Synagis, as well as as a long-acting formulation that requires only one injection during a typical 5-month RSV season, while Synagis needs one dose per monthThe MEDI8897 development also includes a Phase III clinical study in late-term premature infants and healthy full-term infantsAstraZeneca will also conduct a Phase II/III study to generate more data for this group among pediatric patients eligible for Synagis
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