AstraZeneca: Forxiga greenlighted by the AdCom

BUY, Fair Value  3580p (+4%)

News published on December Friday 13, 2013
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Forxiga (dapagliflozin), BMS and AstraZeneca’s jointly-developed SGLT-2 inhibitor was supported yesterday by a favourable vote from the experts of the Advisory Committee as a type II diabetes treatment. The agency will now have to decide whether to grant the drug a final approval by
11 January 2014 and, if it follows the advice given by the panellists, Forxiga would be the second-in-class SGLT-2 inhibitor to reach the US market after J&J’s Invokana. Interestingly, the latter received a CRL asking for more data to support the approval as a fixed-dose combination with metformin, which should help AstraZeneca close the gap vs competition. This would be an important addition to the Diabetes franchise that so far has not delivered on promises as a key growth platform.

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