* Panel votes 13-1 to recommend approval of dapagliflozin
* Follows rejection of drug by U.S. regulators in Jan 2012
* Consensus forecast points to sales of $806 mln in 2019
* AstraZeneca shares gain 2.2 percent
* Diabetes news overshadows mixed data on Astra gout drug
By Ransdell Pierson and Ben Hirschler
Dec 13 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 On
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
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
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
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
"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.