New medicine for nose python! The FDA has approved Roche Xolair's new adaptive disorder, Target Blocking IgE to shrink nasal diphernx and improve symptoms

December 05, 2020 // -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Xolair (Chinese brand name : Umalizumab, generic name: omalizumab, otoxymetin) A new adaptive disorder, as an additional (add-on) maintenance therapy, used to treat adult patients with nasal polyps who do not respond well to nasal corticosteroids (≥18 years old).
phase III clinical data show that Xolair treatment reduces the size of nasal dips (defined by nasal diopharia score (NPS) and improves patients' symptoms and quality of life.
Nasal python is a chronic disease that can lead to loss of sense of smell and nasal congestion, and often occurs at the same time as other respiratory diseases such as allergies and asthma, seriously impairing the quality of life of the patient, with symptoms including long-term nasal congestion, difficulty breathing and sleeping, loss of sense of smell.
it's worth noting that Xolair is the first biologic agent specifically targeted and blocked by immunoglobulin E (IgE), a key driver of inflammatory pathogenesis of the disease.
Xolair's approval will provide a new treatment option for nasal polyp patients in the U.S. who receive nasal corticosteroids that do not adequately control their condition. "In two key Phase III studies, we observed a significant reduction in nasal polyps volume and nasal congestion symptoms in patients with nasal polyps," said Joseph Han, director of nasal and allergy at East Virginia School of Medicine and an investigator in clinical trials of
POLYP 1 and POLYP 2.
these patients usually have other respiratory and allergic symptoms that may worsen.
approval, Xolair offers a new option for treating these patients.
"s Nasal Polyps (Photo: myhealthandwellnessinfo.com) this new adaptation approval is based on the results of two Phase III clinical studies (POLYP 1, POLYP 2).
The two studies, randomized, multi-center, double-blind, placebo-controlled, and repeated Phase III studies, evaluated the efficacy and safety of Xolair in adult CRSwNP patients who did not respond well to standard care therapies (endotholic corticosteroids, INC).
138 patients in the POLYP 1 study and 127 patients in the POLYP 2 study, including those with or without a history of surgery. in
studies, these patients received subsection injections of Xolair or placebo every 2-4 weeks, as well as INC (Momisone Nasal Spray) as a background therapy, and the common main endpoints of both studies were changes in nasal diopolysis score (NPS) over 24 weeks of treatment and changes in the average daily nasal congestive score (NCS) relative baseline.
the results of these two studies were published in the Journal of Perverted Response and Clinical Immunology (JACI) in June 2020.
data show that both studies reached a common primary endpoint: patients in the Xolair treatment group had an average NPS in the 24th week of treatment (POLYP 1:-1.08, p-lt;0.0001; POLYP 2:-0.9) compared to the placebo group. Significant statistical improvements have been made in 0, p-0.014) and daily NCS (POLYP 1:-0.89, p-0.0004; POLYP 2:-0.70, p-0.0017).
two studies, patients in the Xolair treatment group showed significant improvements in NPS and NCS as early as the first assessment (week 4) compared to patients in the placebo group.
In addition, two studies reached a critical secondary endpoint: patients in the Xolair treatment group showed improvements in nasal sinus outcome tests -22 scales (SNOT-22) assessed health-related quality of life, the University of Pennsylvania Olfactory Identification Test (UPSIT), total score of nasal symptoms (TNSS), olfactory improvement, and post-nose DDTs (rear nose leaks) and runny noses (front nose leaks) compared to the placebo group.
two studies, Xolair was well-to-do and its safety was consistent with previous studies.
nasal polyp is a common and potentially debilitating disease, and there are currently limited treatment options, with surgery and systemic steroids being the primary treatments after standard care.
, however, these methods are often not effective in controlling long-term chronic symptoms due to the regeneration of nasal psychics.
non-cancerous lesions of the sinuses or the inner wall of the nasal cavity, accompanied by irritation and inflammation, can block normal airflow.
Nasal psychics are often associated with other respiratory diseases, affecting about 45% of adults with onset asthma and about 30% of patients with chronic nasal-sinusitis, which can lead to chronic nasal-sinusitis with nasal psychics (CRSwNP) if symptoms of nasal and sinusitis appear for 12 weeks or more.
sinus surgery, the recurrence rate of nasal psalms is as high as 80%, and about 40% require at least one additional operation.
about 80% of patients remain unable to control it 3-5 years after sinus surgery.
it is worth noting that in June and October 2019, Sanofi and the regenerative anti-inflammatory drug Dupilumab was approved by the United States and the European Union to treat under-controlled CRSwNP adult patients.
in the United States and the European Union, Dupixent was the first biological therapy to be approved for CRSwNP.
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 promoted by Roche's Genentek in partnership with Novaral, while outside the U.S. market was owned and recorded for sale by Novarter.
In China, Xolair (Chinese brand name: roxy, generic name: Omaju monoantigen) was approved in August 2017 to treat patients over 12 years of age with moderate-severe asthma with poor control of allergies through inhalation hormone combination long-acting beta-2-adrenaline-adrenaline-infestors.
the approval, making Xolair the first targeted drug approved in China to treat asthma.
() Origin: FDA approves Xolair? (omalizumab) for adults with nasal polyps。