Johnson & Johnson is celebrating after advisors to the US Food and Drug Administration recommended approval for the diabetes treatment canagliflozin, despite safety concerns.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 in support of canagliflozin. If approved, the selective sodium glucose co-transporter 2 (SGLT2) inhibitor will be the first in that class to get the thumbs-up in the USA and it will be sold as Invokana.
Data presented at the meeting included results from a Phase III programme, which enrolled 10,285 patients in nine studies and is "the largest late-stage development programme for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date", J&J says.
However, the committee also voted 8 to 7 that they had concerns about potential cardiovascular risks, while some panel members recommended that patients with impaired kidneys should not be given the drug. These concerns were voiced by FDA staffers earlier this week who also noted possible bone-related side effects.
Still, J&J is happy with the vote, and Peter Stein, head of diabetes at the company's Janssen unit, said "we are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the USA".
Last year, AstraZeneca and Bristol-Myers Squibb's SGLT2 inhibitor Forxiga (dapagliflozin) was rejected by the FDA on safety concerns, although it did win clearance in Europe, while Boehringer Ingelheim and Eli Lilly have this week presented more positive data on empagliflozin.
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