Tags : Maintenance

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat

Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi […]Read More

Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from

Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies. Patients who completed the maintenance period up to 52wks. (randomized completers) or who achieved clinical response @14wks. (non-randomized 14wks. responders) after a […]Read More

Novartis’ Enerzair Breezhaler Receives the EC’s Approval as a Maintenance

Shots: The approval is based on P-III IRIDIUM study assessing Enerzair Breezhaler (qd) vs Atectura Breezhaler (QMF149; IND/MF) in 3092 patients in the ratio (1:1:1:1) whose asthma is uncontrolled with LABA/ICS SOC treatment which resulted in improvement of ACQ-7 score @26wks., reductions in asthma exacerbation rates were observed in moderate-to-severe and safety profile was consistent […]Read More

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s

Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks […]Read More

GSK Reports Results of Zejula (niraparib) in P-III PRIMA Study

Shots: The P-III PRIMA study involves assessing of Zejula (200 mg, qd) vs PBO as 1L maintenance therapy in patients in a ratio (2:1) with stage III or IV ovarian cancer following platinum-based chemotherapy The P-III PRIMA study resulted in meeting its 1EPs i.e, improvement in PFS in women regardless of their biomarker status, safe […]Read More