Shots: The P-III BLISS-LN study involves assessing of IV belimumab 10 mg/kg + standard therapy vs PBO in 448 patients with active lupus nephritis for 104 wks. P-III BLISS-LN study results: met 1EPs and all major 2EP; Primary Efficacy Renal Response (PERR) (43% vs 32%); showed consistent safety results; ORR was defined as complete […]Read More
Tags : IV
Shots: The study involves assessing multistem therapy (IV)(n=20) vs PBO (n=10) in patients with ARDS for 28 days Study results: Lower mortality (LM)(25% vs 40%); VF days (12.9 vs 9.2); ICU-free days (10.3 vs 8.1); In severe ARDS: LM (25% vs 50%); ventilator-free (VF)@ days (14.6 vs 8.0); ICU-free @days (11.4 vs 5.9) and was […]Read More
Shots: The approval is based on P-III HELP study results assessing Takhzyro (300 mg q2w, 300 mg q4w, 150 mg q4w) vs PBO in 125 patients with HAE aged ≥12 yrs. P-III HELP study results: no. of monthly attacks (87%, 73%); fewer moderate to severe attacks 83%; attacks that needed on-demand treatment 87% ; reduction […]Read More