FDA panel backs Bristol, AstraZeneca diabetes drug after earlier rebuff

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A new type of diabetes drug from Bristol-Myers Squibb and AstraZeneca has been endorsed by U.S. medical experts, two years after it was rejected by regulators because of safety concerns.

By a lopsided vote of 13 to 1, the advisory panel to the U.S. Food and Drug Administration voted on Thursday to recommend approval of dapagliflozin and said the benefits of the medicine appeared to outweigh its risks.

The FDA typically follows the advice of its advisory panels, but is under no obligation to do so.

In another vote, by 10 to 4, the panel found the drug appeared to have a favorable cardiovascular safety profile.

The FDA rejected the medicine in January 2012 after a previous medical advisory panel said clinical data did not provide enough certainty about its cancer and heart risks.

The latest panel decision is therefore a relief for the two drugmakers and will help consolidate analyst forecasts for the medicine. That is particularly welcome for AstraZeneca, which is struggling with a thin pipeline of new drugs and reported mixed results with a new gout drug on Friday.

Shares in AstraZeneca rose 2.2 percent by 0945 GMT (4:45 EDT) On Friday.

Andrew Baum, an analyst at Citi, said FDA approval of dapagliflozin would also open the door for fixed-dose combinations of the drug with the older medicine metformin, as well as potentially with Bristol and AstraZeneca's Onglyza.

The new drug, which is already sold in Europe under the brand name Forxiga, blocks SGLT2, a protein that works independently of insulin to lower blood sugar. By blocking the kidney from reabsorbing blood sugar, the drug spurs removal of glucose through the urine.

Johnson & Johnson recently won approval for a rival SGLT2 drug called Invokana, or canagliflozin, sales of which have been surprisingly strong, underlining the commercial potential of the drug class.

Invokana stirred excitement in one large trial by controlling blood sugar better than Merck & Co's Januvia, a blockbuster drug that belongs to a different and relatively new class of diabetes treatments called DPP4 inhibitors.

Analysts, on average, forecast worldwide sales of $806 million for dapagliflozin in 2019, according to consensus estimates compiled by Thomson Reuters Pharma.


Some members of the FDA advisory panel, in a day-long meeting on Thursday, expressed concern that 10 patients taking dapagliflozin in a large trial were later diagnosed with bladder cancer.

But other panel members said six of those cases occurred within months after treatment began, and were therefore probably not related to the drug because the cancer typically takes years to develop.

Others noted that the overall incidence of all cancers in patients taking dapaglifozin was similar to the overall incidence seen in patients who received placebos.

"I don't think we can dismiss it," referring to the bladder cancer risk, said panel member Dr. Milton Packer, a cardiologist and chairman of clinical sciences with the University of Texas Southwestern Medical Center in Dallas.

Packer said he was counting on the FDA to require the possible bladder risk to be included in the drug's package insert label.

"I actually really like this drug," Packer said, noting that the diabetes drug lowers blood pressure and causes weight loss, unlike many diabetes drugs that cause weight gain.

Bristol-Myers and AstraZeneca in July resubmitted their U.S. marketing application for dapaglifozin for treatment of adults with type 2 diabetes, the most common form of diabetes that is highly linked to obesity.

The revised application included data from several new studies and additional long-term data from studies previously submitted to the FDA.