FDA extends review on Dynavax’s Heplisav-B

The fate of the vaccine against hepatitis B, Heplisav-B, from the company Dynavax is now being decided. The FDA request for more detailed information on post-marketing surveillance plans for the vaccine slightly reduced the company’s shares, but both managers and analysts said they remain confident in the approval of the drug.

Given the closeness of the FDA’s action date for the vaccine on August 10, Dynavax said that after discussion with the agency they have agreed to extend the review date for up to three months to finalize details of the postmarketing study.

The agency’s request mainly centers on ensuring accurate, timely collection of real-world safety data from Heplisav-B use.

According to the current plan, Dynavax intends to get ahead in the confrontation with GlaxoSmithKline’s Engerix-B in the US in early 2018. The company proposes to conduct the phase 4 study in collaboration with Kaiser Permanente to monitor medical records for 20,000 people taking Heplisav-B against 20,000 people in 12-month GSK surveillance.

Because of the slightly large number of patient deaths during the tests, the vaccine will be accompanied by a warning of possible side effects. However, this is unlikely to affect sales, as the results of the testing did not find the connection of deaths directly with vaccination. Most likely, the Heplisav-B vaccine will be sold very well around the world, as there is a high demand for hepatitis B prevention.

Source: fiercepharma.