The FDA and Liraglutide

On April 2nd, right after the saxagliptin meeting, the FDA Advisory Committee discussed liraglutide, a once-daily injectable medication for type 2 diabetes that works in a way similar to Byetta--it's a member of the GLP-1 class. We've been looking at this drug with anticipation for a long time now; convenient dosing may offer advantage for patients, all else equal. However, this time the Advisory Committee voted not to approve liraglutide, based on concerns about a specific cancer in laboratory animals--while no increased risk of that cancer has been seen in people taking liraglutide, the committee voted that they couldn't rule out the risk. There was a tie in the committee on whether or not liraglutide should be approved so the FDA has the next move. Because of the tie, we are now in the midst of a delay for liraglutide--we aren't sure yet what the FDA will do based on the Advisory Committee's recommendation, but we certainly hope they look to make more safe alternatives available for patients based on high need. Currently there are over 9 million patients in the US estimated to have A1c above the target range of 7% and many more globally. Liraglutide did recently receive a positive opinion from regulatory authorities in Europe, and we would expect to see it on the market there in the next couple of months. We don't know yet the details on regulatory agency differences in opinions on liraglutide, but we'll keep you updated…