American medical expert has approved a new type of diabetes medicine from AstraZeneca plc (ADR) (NYSE:AZN) and Bristol-Myers Squibb Co (NYSE:BMY), two years after it was disallowed by regulators because of safety concerns. By an uneven vote of 13 to 1, the advisory panel to the American FDA voted to recommend approval of dapagliflozin and said the benefits of the medicine appeared to offset its risks.
In January 2012, the Food and Drug Administration rejected the medicine after a previous medical advisory panel said clinical data did not give sufficient surety about its cancer and heart risks. The recent panel decision is therefore a relief for the both firms and will help consolidate analyst estimates for the medicine.
Citi’s Andrew Baum, said Food and Drug Administration approval of dapagliflozin would also open the door for fixed dose combinations of the medicine with the older drug metformin, as well as potentially with AstraZeneca plc (ADR) (NYSE:AZN) and Bristol-Myers Squibb Co (NYSE:BMY)’s Onglyza. In Europe, the new medicine is already sold under the brand name Forxiga, blocks SGLT2 that works individually of insulin to lower blood sugar.
In yesterday meeting, some members of the advisory panel showed concern that ten patients taking the new drug in a large experiment were later diagnosed with bladder cancer. But other panel members argued that six of those cases arose within months after treatment began, and were therefore possibly not associated to the medicine because the cancer typically takes years to develop.
Recently, Johnson & Johnson (NYSE:JNJ) won approval for a competitor SGLT2 drug called canagliflozin or Invokana, sales of which have been amazingly strong, underlining the commercial potential of the drug class. Invokana stimulated excitement in one large trial by controlling blood sugar better than Merck & Co., Inc. (NYSE:MRK)’s Januvia. According to consensus projections compiled by Thomson Reuters Pharma, analysts, on average, estimate international sales of $806 million for dapagliflozin in 2019.