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August 14, 2020 // -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental biologics licensing application (sBLA) from the U.S. Food and Drug Administration (FDA): A new self-administration option for Xolair (Chinese commodity name: Shro, generic name: omalizumab, otamaju monoantigen) for the drug's approved full-term adaptation in the United States.
FDA is expected to make an approval decision in the first quarter of 2021.
In the United States, Xolair is currently approved for use by healthcare providers in healthcare facilities and is the only biological agent approved to target block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma and chronic idiotic urticaria (CIU).
, Chief Medical Officer and Head of Global Product Development at Roche, said, "Due to the COVID-19 pandemic, there is an urgent need to provide our patients with Xolair self-dosing options, especially those considered to be at high risk of serious illness.
look forward to working closely with the FDA and introducing Xolair self-administration options as soon as possible, giving patients more flexibility to manage their treatment needs.
"If approved, once Xolair treatment has been established and is closely monitored by the healthcare provider, the patient or caregiver may use Xolair pre-charged syringes on his own outside the medical environment and may be considered suitable by the healthcare provider for the selected patient."
these cases, the patient or caregiver will receive proper training in the correct off-the-cortitis technique from the healthcare provider and identify early signs and symptoms of an allergic reaction.
, Roche's Geneneck and Novarma have teamed up to develop and promote Xolair.
2003, about 460,000 patients in the United States have received Xolair treatment since it was first approved for treatment of allergic asthma.
Xolair's use in allergic asthma and CEU is supported by strong clinical development projects, including 8 Phase III studies.
independent clinical studies of Xolair treatment in patients with allergic asthma and CIU patients have shown that Xolair can self-medication through appropriate training and monitoring.
Xolair is the only approved anti-IgE antibody drug that specifically targets binding and blocks IgE.
Xolair minimizes the release of media during astrological inflammation cascading by reducing free IgE, lowering high affinity IgE subjects, and limiting granulation of large fat cells.
The drug is an injectable prescription drug that has been approved in several countries around the world for treatment: moderate to severe persistent allergic asthma (SAA), chronic spontaneous urticaria (CSU) and chronic idiotic urticaria (CIU).
addition, Xolair pre-charged syringes have been approved for sale in several countries around the world.
the U.S. market, the drug was developed and marketed by Roche's Genentek in partnership with Novaral, while outside the U.S. market was owned and recorded for sale by Novarter.
earlier this month, Xolair was approved in the European Union for a new adaptive disorder: an additional (add-on) therapy for endostrophic corticosteroids (INC) to treat adult patients with severe chronic nasal-sinusitis (CRSwNP) that is not adequately controlled by INC.
phase III study showed that Xolair reduced the size of nasal dips (defined by nasal dips scoring (NPS) and improved symptoms and quality of life in CRSwNP patients.
CRSwNP is a chronic disease that often occurs at the same time as other respiratory diseases and seriously impairs the quality of life of patients, including long-term nasal congestion, difficulty breathing and sleeping, and loss of sense of smell.
it is worth noting that Xolair is the first therapy specifically targeted and blocked by IgE to treat CRSwNP, a key driver of the inflammatory pathland of the disease.
approval of Xolair will provide a new treatment option for CRSwNP patients in Europe who are unable to fully control their condition and can significantly improve their symptoms and quality of life.
In China, Xolair (Chinese brand name: Ulster, generic name: Omaju monoanti) was approved in August 2017 to treat patients over 12 years of age with moderate to severe allergic asthma who are poorly controlled with inhaled hormone-combined long-acting beta-2-adrenaline-inhibitor astrists.
the approval, making Xolair the first targeted drug approved in China to treat asthma.
() Original origin: FDA accepts application for Xolair (omalizumab) prefilled syringe for self-administration all all points.