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

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.

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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.

- read the release

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