All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

News

Article

September 23, 2019

AstraZeneca’s Combination Diabetes Pill Recommended for Approval in EU

Author(s):

Pharmaceutical Technology Editors

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

On Sept. 23, 2019, AstraZeneca announced that Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablet, its combination diabetes medicine, has been recommended for marketing authorization in the European Union by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for treating adults with type-2 diabetes.

CHMP based its positive opinion on data from five Phase III trials that evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of metformin in patients with inadequately controlled type-2 diabetes. Across the trials, the combination of Forxiga, Onglyza, and metformin was superior in reducing hemoglobin A1c (HbA1c) versus Forxiga combined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin, AstraZeneca reported. The combination of Forxiga, Onglyza, and metformin with or without sulphonylurea (SU) was non-inferior to the combined use of insulin and metformin with or without SU in reducing HbA1c.

CHMP recommended the marketing authorization for Qtrilmet to improve glycemic control when metformin with or without SU and either saxagliptin or dapagliflozin does not provide adequate glycaemic control, or when type 2 patients are already being treated with metformin, saxagliptin, and dapagliflozin.

Qtrilmet is approved in the United States under the name Qternmet XR as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.

Source: AstraZeneca

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content
Advertisement
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Oil painting of maze with figure finding way through. Perseverance, problem-solving. Birds fly above labyrinth at sunset. Concept of challenges, resilience, journey, overcoming obstacles in business | Image Credit © Vadym - stock.adobe.com
July 25th 2025

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Christopher Cole
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
Mercury. Element 80 of the periodic table of chemical elements. | Image Credit: © N. Elkha - stock.adobe.com
July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery
Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com
July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt
Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
Related Content
Advertisement
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Oil painting of maze with figure finding way through. Perseverance, problem-solving. Birds fly above labyrinth at sunset. Concept of challenges, resilience, journey, overcoming obstacles in business | Image Credit © Vadym - stock.adobe.com
July 25th 2025

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Christopher Cole
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
Mercury. Element 80 of the periodic table of chemical elements. | Image Credit: © N. Elkha - stock.adobe.com
July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery
Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com
July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt
Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.