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AZN Astrazeneca Plc

11,988.00
-38.00 (-0.32%)
26 Apr 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Astrazeneca Plc LSE:AZN London Ordinary Share GB0009895292 ORD SHS $0.25
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -38.00 -0.32% 11,988.00 12,014.00 12,018.00 12,144.00 11,882.00 12,070.00 2,340,814 16:35:09
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 45.81B 5.96B 3.8415 31.28 186.27B

AstraZeneca's Calquence Tablet Formulation Gets FDA Approval

05/08/2022 12:59pm

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By Anthony O. Goriainoff

 

AstraZeneca PLC said Friday that its lymphoma treatment Calquence's tablet formulation has been approved by the U.S. Food and Drug Administration for all current indications.

The Anglo-Swedish pharmaceutical giant said the approval was based on results from the Elevate-Plus trials where it was shown that Calquence's capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.

The company said Calquence, or acalabrutinib, was also approved as a capsule formulation for the same indications as the tablet in the U.S. and in many other countries around the world.

"Today's approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment," the company said.

Shares at 1119 GMT were up 90 pence, or 0.8%, at 10,810 pence.

 

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

 

(END) Dow Jones Newswires

August 05, 2022 07:44 ET (11:44 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.

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