Tags : sNDA

GSK and Innoviva’s Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA’s

Shots: The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd, 100/62.5/25, 200/62.5/25, 100/31.25/25, and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA Results: Trelegy (qd, easy-to-use inhaler) demonstrated improvements in lung function, presented at ERS Congress. The […]Read More

Astellas Reports Submission of sNDA to MHLW for Evrenzo (roxadustat)

Shots: The sNDA is based on three studies in 500+ patients with NDD-CKD. The first P-III study involve assessing Evrenzo vs darbepoetin alfa resulted in meeting 1EPs of non-inferiority and maintenance of Hb levels over time and is well tolerated The other two studies (one P-II & one P-III) supported the safety and efficacy in […]Read More

Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to

Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in […]Read More

AbbVie Announces FDA’s Acceptance of sNDA for PR for Imbruvica

Shots: The sNDA application is based on results of P-III iLLUMINATE (PCYC-1130) trial assessing Imbruvica (420) + Obinutuzumab (1000) vs chlorambucil (Days 1 & 15) + obinutuzumab (1000) over 6 cycles in patients with 1L CLL/SLL The iLLUMINATE study demonstrated 1EP as PFS, which showed longer PFS rate for Imbruvica + Obinutuzumab vs chlorambucil + […]Read More