AstraZeneca Fasenra automatic injection pen approved by FDA can be self-injected at home

Fasenra's self-administering options and Pasenra pen have also been approved in the European UnionFasenra is currently approved as an additional (add-on) maintenance therapy in the United States, the European Union, Japan and other countries for the treatment of patients with severe eosinophilic pneumocodone asthmaself-medication, Fasenra will be injected with a fixed dose of 30 mg subcutaneous injection stonewary through a pre-filled syringe or Fasenra injection pen (both using 29 thin needles), with the first 3 injections being injected every 4 weeks and then every 8 weeksFasenra injection pens allow patients and caregivers to manage administration through a simple two-step process that includes an observation window and a click that can be heard at the beginning and end of the injection to guide the patient through successful medicationthis approval, based on the support of Phase III clinical study GRECO and a Phase I clinical study AMES, the safety observed in these two studies is consistent with that of other studies, with no new or unexpected safety aspects:- GRECO study is an open label 28-week study, including 120 patients with severe uncontrolled asthma, evaluating the use of precharged auto-injector (Fasenra) at clinics and at home at 30mg a dose of fasenData show that in weeks 12 and 16, the vast majority (97%) of patients or caregivers successfully used pre-charged auto-injectors at homeAt weeks 12 and 16, the vast majority of pre-chargeautod scars (97%) used at home and returned were assessed as functional- AMES study is an open label Phase I health subject study that assessed pharmacokinetics (PK) or exposure after a single dose of Fasenra by administering a 30mg dose of Fasenra using a pre-charged syringe or pre-charged auto-injectorThe results showed that Fasenra PK exposure was comparable in two ways of subcutaneous injection, and that the eosinophils of the two groups were rapidly reduced"Fasenra is the only respiratory preparation that is given every eight weeks after the initial load dose period," said Mene Pangalos, executive vice president of research and development at AstraZeneca Biopharmaceuticals,Today's approval means that we can now provide Fasenra in a more convenient way, so that U.Shealth care providers and patients can choose to use Fasenra at home or in the doctor's office, which will make it easier for patients with severe acidophilic asthma to get treatmentFasenra PenFasenra's active pharmaceutical ingredient is benralizumab, a monoclonal antibody that directly binds to the alpha sub-sub-base (IL-5R alpha) of the leukocyte interleukin 5 receptor on eosinophils and uniquely attracts naturally killing cells (cat-en-cells) to induce rapid and almost complete depletion of eosinophils through cell apoptosis (procedural cell death)Fasenra was authorized by AstraZeneca from BioWa, a wholly owned subsidiary of Japanese pharmaceutical company Coju and Fermentation KirinAt the end of March this year, AstraZeneca signed a new agreement with Concord Fermentation Kirin, which acquired the Asian rights to Fasenra's full indications In addition to approved eosinophilic asthma indications, AstraZeneca is also evaluating fasenra's potential to treat severe nasal polyps, eosinophilic esophageal itisis (EoE), high eosinophilsyndrome syndrome (HES), eosinophilic granotitis (EGPA), and chronic obstructive pulmonary disease Previously, the FDA had granted Fasenra the right to treat Orphan Sass, HES, eGPA original origin: Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen