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.
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
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.
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.
No significant impact on imputed arterial partial pressure of oxygen to fraction of inspired oxygen ratio at seven days
Breyna is a metered-dose inhaler containing budesonide, a corticosteroid, and formoterol, a long-acting bronchodilator.
Azithromycin therapy during RSV bronchiolitis does not reduce the risk for post-RSV recurrent wheeze over 2 to 4 years.
The sBLA includes data from the phase 3 OSTRO study, which showed that treatment with subcutaneously administered benralizumab led to statistically significant improvements.
The Agency issued the notification order as it deemed the Company’s notification efforts to be inadequate.
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 is a long-acting monoclonal antibody to the RSV fusion protein that has an extended half-life.