New medicine for nasal polyp! The new indications of Roche xolair (omazumab) are under review in the United States, targeting to block IgE to reduce nasal polyps & improve symptoms!

December 12, 2019 / BIOON / -- Roche recently announced that the U.S Food and Drug Administration (FDA) has accepted an application for permission to supplement biological products (SBLA) from xolair (omalizumab), which is used to treat nasal polyps for adults aged 18 and over who have insufficient response to intranasal corticosteroid treatment FDA is expected to make a decision to approve the indication in the third quarter of 2020 Nasal polyp is a chronic disease, which often occurs at the same time with other respiratory diseases, and causes a series of symptoms that affect patients' lives, including loss of smell and nasal congestion If approved, xolair will be the first antibody drug to help reduce the size of nasal polyps and improve symptoms by targeting and blocking immunoglobulin E (IGE) Levi Garraway, MD, chief medical officer and head of global product development at Roche, said: "nasal polyps may limit a patient's ability to breathe and smell normally and lead to other symptoms that may have a negative impact on their lives For millions of people with the disease, there is an urgent need for new treatments The results of our two phase III studies of nasal polyps further deepen our understanding of xolair as a potential option for the treatment of allergic respiratory diseases and related comorbidities " The SBLA is based on the results of two phase III clinical studies (polyp 1, polyp 2) These two studies were randomized, multicenter, double-blind, placebo-controlled, repeat phase III studies to evaluate the efficacy and safety of xolair in adult patients with crswnp who did not respond to standard care therapy (intranasal corticosteroids) There were 138 patients enrolled in the study of polyp 1 and 127 patients enrolled in the study of polyp 2, including patients with or without surgical history In the study, these patients were subcutaneously injected with xolair or placebo every 2-4 weeks The common primary end point was the change of nasal polyp score (NPS) relative to the baseline and the change of average daily nasal congestion score (NCS) relative to the baseline within 24 weeks The results showed that both of the two studies reached a common primary end point: patients in the xolair group showed statistically significant and clinically relevant improvements in NPS and NCS relative to baseline within 24 weeks of treatment compared to the placebo group In addition, two studies also reached key secondary endpoints, including olfactory improvement, postnasal drip (postrhinorrhea score), runny nose (anterior rhinorrhea score), and health-related quality of life assessed by the SNOT-22 In the two studies, xolair was well tolerated, and its safety was consistent with that of previous studies in patients with moderate to severe allergic asthma and chronic idiopathic urticaria No new unexpected safety signals were found Nasal polyps are common and debilitating diseases in adults, affecting 13 million people in the United States At present, the treatment options are limited, many patients choose nasal surgery or systemic steroid treatment, which is often unable to effectively control the symptoms of nasal polyp regeneration over time Nasal polyps are non cancerous lesions of the sinuses or the inner walls of the nasal cavity, accompanied by irritation and inflammation, which can block the normal airflow Nasal polyps often occur together with other respiratory diseases, affecting about 45% of adult patients with paroxysmal asthma and about 30% of patients with chronic rhinosinusitis If the symptoms of nasal polyps and sinusitis occur for 12 weeks or longer, chronic rhinosinusitis with nasal polyps (crswnp) will result After sinus surgery, the recurrence rate of nasal polyps is as high as 80% About 40% of them need at least one further operation It is worth mentioning that, at the end of June this year, Sanofi and dupilumab, the anti-inflammatory drug of Zaihuan, were approved by the US FDA to treat adult patients with crswnp who were under control Indications were approved through the priority review process Dupixent is the first approved biotherapy for crswnp in the United States and the European Union Xolair is the only antibody drug approved to target and block immunoglobulin E (IGE) By reducing free IgE, down regulating high affinity IgE receptor and limiting mast cell degranulation, the release of mediators in allergic inflammatory cascade is minimized It is a prescription drug for injection It has been approved by many countries in the world for treatment by subcutaneous injection: moderate to severe persistent allergic asthma (SAA), chronic spontaneous urticaria (CSU) and chronic idiopathic urticaria (CIU) In 2018, xolair's global sales were close to $3 billion In the U.S market, the drug is developed and promoted by Roche's Genentech in cooperation with Novartis, while in the markets outside the U.S., Novartis is responsible for and records sales In China, xolair (Chinese brand name: Zhuolu, generic name: omazumab) was approved in August 2017 for the treatment of moderate to severe allergic asthma patients over 12 years old who were poorly controlled by inhaling hormone and long-acting β 2-adrenergic receptor agonist This approval makes xolair the first target drug approved for asthma treatment in China Original source: FDA accepts supplementary biology license application for xolair (omnizumab) for the treatment of nasal polyps