FDA approves AZ's Farxiga (dapagliflozin)

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LOEs continue to buffet AstraZeneca
LOEs continue to buffet AstraZeneca

Farxiga (dapaglifozin), the SGLT-2 inhibitor that was set to be co-marketed by Bristol-Myers Squibb and AstraZeneca before BMS broke free of the partnership late last year, was given the nod for marketing today by the FDA. It's the second treatment of its kind available in the US behind Johnson & Johnson's Invokana (canagliflozin).

SGLT-2 inhibitors offer HbA1c and weight control in one pill, differentiating them in the crowded field of diabetes treatments.

Morningstar analyst Damien Conover forecast Farxiga annual sales reaching about $1.5 billion by 2018, reported Reuters.

Last year AZ purchased the BMS portion of their diabetes joint venture, including full ownership of dapagliflozin and several other drugs, for $2.7 billion upfront and up to $1.4 billion in milestone payments, in addition to royalties.

Dapagliflozin was poised to be first-in-class in the SGLT-2 category, but Invokana stole a march after an advisory committee voted down the drug in 2011 due to possible cancer and heart risks, leading to regulatory delays. An advisory panel gave it a thumbs-up this past December, after the companies showed the FDA more data.

Wells Fargo analyst Lawrence Biegelsen forecast last year that Invokana would bring in $111 million in 2013, with a bump to $667 million in 2016, as reported by The New York Times, following its approval by the FDA on March 29, 2013. In its first quarter on the market, J&J saw "strong sales results" for the drug, the company said in a third-quarter SEC filing.

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