Provention’s diabetes project takes a tentative step forward

A 10-7 advisory committee vote in favour of approving teplizumab to delay the onset of type 1 diabetes is a step in the right direction for Provention’s project. But it is far from the end of the road. For a start there are FDA concerns about pharmacokinetic inconsistencies between the MAb used in the clinic and the one Provention plans to take to market; regardless of the agency's opinion on approvability, the issue is thought likely to result in the July 2 Pdufa date being missed. Other concerns raised by the panel included the small sample size, with only 44 patients receiving teplizumab, and lack of long-term safety data. The panellists and the FDA seem to agree that a 32.5-month delay in median time to clinical diagnosis is meaningful, but it is easy to see why the agency might choose to tread cautiously here. Another aspect troubling investors is the commercial potential of this opportunity, which in the short term would be hampered by the lack of effective ways to identify at-risk people, outside of having close relatives with the disease. The harsh realities facing Provention won out this morning, with the stock opening off 14%.