logo
Plus   Neg
Share
Email

AstraZeneca Reports Results From Cardiovascular Safety Analyses On Roxadustat

British drug major AstraZeneca Plc (AZN.L,AZN) said that pooled analyses of the roxadustat global Phase III programme confirmed cardiovascular safety. Cardiovascular safety endpoints evaluated across chronic kidney disease patients not on dialysis, on incident dialysis and on stable dialysis.

The global pivotal Phase III trials evaluated roxadustat for treatment of anaemia in patients with chronic kidney disease across the non-dialysis-dependent, incident (newly-initiated) dialysis, and stable dialysis patient groups.

In the pooled analysis of over 4,300 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and placebo showed no clinically-meaningful difference.

In the pooled analysis of around 4,000 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and epoetin alfa showed no clinically-meaningful difference.

AstraZeneca and FibroGen Inc. said they will begin discussions with the US Food and Drug Administration to prepare for regulatory submission, which is anticipated in the second half of 2019. Roxadustat is currently approved in China for the treatment of patients with anaemia in dialysis-dependent chronic kidney disease.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Intel Corp. said it is probing into the hack of its fourth-quarter earnings report that prompted the chipmaker to release its earnings statement ahead of schedule. The company, which was scheduled to release the results after the market closed, released it before the market closing on Thursday. Google parent Alphabet decided to drop its Internet balloon project Loon that was launched with the idea of providing Internet access to rural areas and providing last mile connectivity. In a blog post, Loon CEO Alastair Westgarth said they have not found a way to get the costs low enough to build a long-term, sustainable business, despite gaining a number of interested partners along the way. American Airlines announced the launch of Flagship Cellars, its home delivery service for premium wines usually available onboard. The airline's move is said to be due to the excess wine it has amid the weakness in air travel demand following the coronavirus pandemic crisis. The company expects the new at-home wine program to generate about $40,000 to $50,000 in sales during the first quarter.
Follow RTT