BioCentury
ARTICLE | Regulation

Aug. 29 Quick Takes: Novartis’ Scemblix wins EU approval in leukemia setting

Plus Farxiga demonstrates survival benefit and a Teva-MedinCell antipsychotic enters Phase III

August 29, 2022 10:24 PM UTC

EMA’s approval of Scemblix asciminib to treat chronic myelogenous leukemia opens up another major market for Novartis AG (NYSE:NVS; SIX:NOVN) as it aims for a goal of $2 billion in peak sales of the drug. The first-in-class BCR-ABL inhibitor may be the most near-term growth opportunity to recently emerge from Novartis’ pipeline; following FDA’s approval the drug in October, it delivered $25 million and $31 million in 1Q22 and 2Q22 sales, respectively.

AstraZeneca plc (LSE:AZN; NASDAQ:AZN) reported results from a pooled analysis of two Phase III trials of Farxiga dapagliflozin showing that the SGLT2 inhibitor reduced the risk of CV death by 14% and all-cause death by 10% in patients with heart failure irrespective of ejection fraction. The company said it was the first heart failure medication to demonstrate a mortality benefit across the full ejection fraction range...