Novo Nordisk discontinues development of a VIIa follow-on analog
Novo Nordisk announced on 28 September 2012 that they are discontinuing further development of their fast-acting follow-on analog of rFVIIa. This decision comes as a result of development of antibodies to this molecule in a phase III trial in hemophilia patients with inhibitors to FVIII or FVIX. During the many years of use of rFVIIa there have been no reports of neutralizing antibodies to it. The newer molecule had a greater number of changes to the molecule, but nevertheless antibody development had not been expected. It is likely that regulatory bodies will now ask for more careful examination of similar FVII molecules should any undergo clinical development. The link to the full announcement is: http://www.novonordisk.com/press/sea/sea.asp?sShowNewsItemGUID=a64ed4f3-6393-4ce7-bb74-4814aa5ec29a&sShowLanguageCode=en-GB
The former ATACCC meeting has been rebranded as "MHSRS" to expand the presence for all services. The meeting was in Fr. Lauderdale 13-16 August 2012. Few surprises were revealed. Severe hemorrhage continues to be the leading cause of battlefield preventable death, and suicide has emerged as an important health concern. Both appear to be viable research opportunities. In the area of blood and blood component research, significant progress has been made in: pathogen reduction, freeze- or spray-dried plasma, and methods of platelet storage/ preservation. While the DOD budget reductions will surely affect medical R&D extramural funding, nevertheless, opportunities continue to exist.
FDA/ NIH/ DOD Workshop on Hydroxyethyl Starches (HES)
An FDA/ NIH/ DOD Workshop on hydroxyethyl starches (HES) was held on the NIH campus in Bethesda on 6-7 September 2012. Several speakers presented data based on studies or reviews. Others expressed their views. Unfortunately, the results of the "CHEST" study were not presented, as had been expected, presumably because the data have not been published or a manuscript accepted for publication.
The atmosphere on the first day was openly anti-starches; this attitude was mitigated somewhat on the second day.
Many expressed concern regarding the limited data that they regarded as demonstrating "efficacy," and their view of the adverse results of the use of HES (at least those tested) in severe sepsis. It is important to note that the HES tested in the "6S" trial (Perner et al.: N Engl J Med 2012; 367: 124-134) was with an HES not approved in the U.S.
Dr. Weiskopf was an invited speaker and panelist. He reviewed the safety of tetrastarches when used in a different clinical context, that of surgery.
The FDA indicated that they will take into account the forthcoming results of the "CHEST" trial in their deliberations. The transcript of the workshop should be available on the FDA website within 3 or 4 weeks.