Posted by Michael Wonder on 04 Aug 2017
Dynavax provides U.S. regulatory update on Heplisav following FDA Advisory Committee meeting
3 August 2017 - Dynavax Technologies Corporation today announced that the U.S. FDA has requested more detailed information about the company's proposed post-marketing study for Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] based on feedback received from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) during a meeting on 28 July 2017.
The Advisory Committee voted 12 to 1 (with 3 abstentions) that the safety data for Heplisav-B support licensure for active immunisation against hepatitis B infection in adults 18 years of age and older while also commenting on the design of Dynavax's proposed post-marketing study for Heplisav-B.
Dynavax and the FDA have discussed the outcome of the VRBPAC meeting and have agreed that due to the feedback provided and the proximity to the scheduled Prescription Drug User Fee Act date of 10 August 2017, more time is required to finalise key details of the post-marketing study.
