Tags : NDA

Regulatory

Agios Reports the US FDA’s Acceptance of NDA and Priority

Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported […]Read More

Regulatory

Gilead Reports Submission of NDA to the US FDA for

Shots: The submission is based on P-II/III CAPELLA trial evaluating the safety & efficacy of lenacapavir (SC, every 6mos.) in combination with other antiretroviral agents vs PBO in 36 THE patients with multi-drug resistant HIV-1 infection The study demonstrated viral load reduction of ≥ 0.5 log10 copies/mL from baseline for 14days functional monothx. period (88% […]Read More

Regulatory

Janssen Reports Submission of NDA to the US FDA for

Shots: The application is based on two studies i.e P-III EINSTEIN-Jr & UNIVERSE. The P-III EINSTEIN-Jr study evaluates Xarelto in 500 children in a ratio (2:1) aged birth to 17yrs. with previously diagnosed VTE, following 5 days of initial parenteral anticoagulation treatment The P-III UNIVERSE study evaluates Xarelto in children aged 2-8yrs. with congenital heart […]Read More