Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
Respiratory Diseases/Disorders
Sabizabulin Cuts COVID-19 Death; Trial Stopped Early Due to Efficacy
The phase 3 trial included approximately 210 patients hospitalized with moderate to severe COVID-19 (WHO ≥4) who were at high risk for ARDS and death.
Tocilizumab Gets Priority Review for Treatment of Hospitalized COVID-19 Patients
The sBLA is supported by data from 4 randomized, controlled studies that evaluated tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients.
Losartan Does Not Reduce Lung Injury in Hospitalized COVID-19 Patients
No significant impact on imputed arterial partial pressure of oxygen to fraction of inspired oxygen ratio at seven days
First Generic Version of Symbicort Gets FDA Approval
Breyna is a metered-dose inhaler containing budesonide, a corticosteroid, and formoterol, a long-acting bronchodilator.
Azithromycin Therapy Does Not Reduce Recurrent Wheeze After RSV
Azithromycin therapy during RSV bronchiolitis does not reduce the risk for post-RSV recurrent wheeze over 2 to 4 years.
FDA Needs More Data to Decide on Benralizumab for Nasal Polyposis
The sBLA includes data from the phase 3 OSTRO study, which showed that treatment with subcutaneously administered benralizumab led to statistically significant improvements.
FDA Tells Philips Respironics to Increase Awareness of Product Recall
The Agency issued the notification order as it deemed the Company’s notification efforts to be inadequate.
Drug-Device Combo Looks Promising for Chronic Sinusitis
OPN-375 is currently marketed under the brand name Xhance for the treatment of nasal polyps in patients 18 years of age and older.
Nirsevimab Looks Promising for Protection Against RSV for All Infants
Nirsevimab is a long-acting monoclonal antibody to the RSV fusion protein that has an extended half-life.
