AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) have a shot to gain the first market green light for a treatment in a new class of diabetes drugs known as SGLT2 inhibitors, with European regulators recommending the companies' therapy dapagliflozin (Forxiga) for approval in April.
The program has not been without challenges, however, as the FDA denied approval of the therapy in January with a complete response letter amid concerns about cancer cases and toxicity seen during development of the drug. The agency asked for more clinical data on the treatment, opening the door for Johnson & Johnson ($JNJ) to potentially beat AZ and BMS to the U.S. market with its own drug in this class.
The drugs offer a different way than insulin therapy to lower blood sugar, preventing excess sugar in the kidneys from reentering circulation and allowing glucose to exit the body via urine.
AstraZeneca and Bristol-Myers Squibb's diabetes alliance, which dates back to January 2007, has enabled the partners to pursue new therapies in several of the new classes of drugs. In addition to dapagliflozin, their initial tie-up included the approved DPP-4 inhibitor Onglyza (or saxagliptin) and a form of the drug combined with metformin called Kombiglyze.
This summer the companies added to their alliance the GLP-1 agonists Byetta and Bydureon from BMS's $5.3 billion buyout of Amylin Pharmaceuticals. Their tie-up also includes metreleptin, a leptin analog under FDA review for rare forms of lipodystrophy that could add to AZ and BMS's arsenal of treatments for diabetics. AstraZeneca forked over $3.4 billion to BMS to gain rights to Amylin's assets.
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Phase: Under FDA review