FDA approves first nasal psychic drug for chronic rhinitis-sinusitis

The U.S. Food and Drug Administration today approved Dupilumab for the treatment of adult patients with nasal diopharmitis (the growth of the inner sinuses) associated with chronic sinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for the control of inadequate chronic sinusitis nasal psalone.“ Nasal polyps can lead to loss of smell, and patients often need surgery to remove polyps," said Dr. Sally Seymour, Director of Lung, Allergy and Rheumatology Products at the FDA Drug Evaluation and Research Center. It also reduces the need for nasal polyp surgery and oral steroids. " Dupixent is given by injection. The effectiveness and safety of Dupixent was determined in two studies, 724 of which were patients aged 18 and older with chronic nasal-sinusitis accompanied by nasal polyp, and who had symptoms despite taking endotholsteroids. Statistically, patients who received Dupixent had significantly lower nasal pynoremia and nasal congestion than the placebo group. Patients taking Dupixent also reported increased olfactory ability, with a small number requiring nasal polyps surgery and taking oral steroids.Dupixent can cause severe allergic reactions and eye problems, such as eye inflammation (conjunctivitis) and corneal inflammation (cornitis). Patients should consult their health care professional if they experience new or worsening eye symptoms, such as redness, itching, pain, or changes in vision. The most common side effects reported include injection site reactions and inflammation of the eyes and eyelids, including redness, swelling and itching. Patients receiving Dupixent should avoid active vaccination.Dupixent was originally approved in 2017 for patients 12 years and older with eczema who cannot be adequately controlled through topical therapy or when these treatments are not desirable. In 2018, Dupixent was approved as an additional maintenance treatment for patients 12 years of age and older with moderate to severe eosinophilic asthma or oral corticosteroid-dependent asthma.
The FDA gives priority to this application. Dupixent's approval was granted to Regenerative Pharmaceuticals. (Compiled by this web)