The Low Carb Diabetic

Promoting a low carb high fat lifestyle for the safe control of diabetes. Eat whole fresh food, more drugs are not the answer.

Welcome to the Low Carb Diabetic forum,have you signed up yet? if not then sign up and join us in the low carb community today!

    AZ's FDA-rejected diabetes combo grabs first-to-market status in Europe


    Status :

    Male Posts : 3378
    Join date : 2014-08-10
    Location : Lancs

    AZ's FDA-rejected diabetes combo grabs first-to-market status in Europe

    Post by graham64 on Wed Jul 20 2016, 21:50

    AstraZeneca ($AZN) may so far be on the outside looking in with its new diabetes combo drug when it comes to the U.S. market. On its home continent, though, it now has a first-mover advantage.

    Tuesday, the European Commission green-lighted Qtern, a pairing of the company’s saxagliptin and dapagliflozin--approved individually as Onglyza and Farxiga--as a treatment for Type 2 diabetes. Regulators based their approval on three trials that paired the med with metformin, including two that showed the cocktail beat placebo at reducing HbA1c.

    Now, AZ can get to work building up market share for the new med, which combines a DPP-4 drug (Onglyza) with an SGLT2 (Farxiga), a newer class. It'll need to act quickly to stake out territory before Eli Lilly ($LLY) and Boehringer Ingelheim launch Glyxambi--which couples the SGLT2 med Jardiance with DPP-4 Tradjenta--arrives.

    The first-to-market advantage in the E.U. could be an important edge for the British drugmaker and Qtern, especially because it’s not yet able to compete with Glyxambi in the U.S.--where its foe won a go-ahead last February.

    That’s not to say AZ hasn’t tried. But last October, the FDA slapped the DPP-4/SGLT2 combo with a costly delay. The agency not only rejected its approval application but also requested more clinical data--potentially even from new studies. At the time, some analysts predicted a launch holdup of up to two years.

    And meanwhile, Lilly and BI have another SGLT2 leg up: Last year, Jardiance showed it could slash incidence of cardiovascular death among high-risk Type 2 diabetes patients by 38%, data an FDA panel recently voted to add to the drug’s label. AZ, for its part, won’t have any outcomes data of its own for Farxiga until 2019 at the earliest, and there’s no guarantee it’ll be able to replicate Jardiance’s success.

    AZ needs both Farxiga and Qtern to come through if it hopes to hit its ambitious sales targets for its diabetes unit. In 2014, the company predicted it would rake in $8 billion by 2023, and its said Qtern could generate $3 billion at its peak.

    Yet another useless drug combo I hope NICE consider the FDA stance before approving it in the UK

    I'm a skinny T2 diagnosed 4/4/2008, a high calorie LCHF diet and one metformin a day A1c 6.2 and no complications.

    Proving the LowCarb sceptics wrong for over ten years

    Not all cherubs are Angels  Wink nor all diabetics Bonkers  Rolling Eyes
    chris c

    Status :

    Posts : 3859
    Join date : 2015-07-26

    Re: AZ's FDA-rejected diabetes combo grabs first-to-market status in Europe

    Post by chris c on Thu Jul 21 2016, 21:32

    Buying shares might be a good plan. Then you can spend the profits on Real Food. Win-win.

      Current date/time is Tue May 22 2018, 18:44