Approved in the EU .
Recommended for EU approval by CHMP - the full indication is "for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older." Its use should be in accordance with official recommendations .
EMA accepts MAA for review .
Company is in the process of finding a suitable distribution partner for UK, before filing in the UK or EU .
HEPLISAV-B was launched in the US in Q1 2018 .
The FDA has approved Heplisav-B. While the company is open to partnering, it intends to market the vaccine early in 2018 whether a partner is found or not. Marketing points will be greater seroconversion rates vs. Engerix-B on a one-month, two-dose schedule .
Assuming final approval by Nov 2017, Dynavax hope to launch Heplisav-B in the US early 2018 .
The review date for approval in the US has been extended by three months (previously set as 10th Aug 2017) to finalise details of the postmarketing study requested the FDA to ensure accurate, timely collection of real-world safety data from Heplisav-B use .
After two earlier attempts came up short, an FDA Advisory Committee has favoured Dynavax’s hepatitis B candidate Heplisav-B by a vote of 12 to 1, with three abstentions, although concerns were again expressed over safety and sufficiency of the proposed design of the postmarketing surveillance program. However the committee recognised the stronger protection offered by Heplisav vs. Engerix B (95% vs. 81% seroprotection), and that the two-dose regimen over one month compared to three doses over 6 months offered the potential to improve compliance. The company have announced they are willing to work with the FDA for an appropriate postmarketing pharmacovigilance program, and US launch is expected in 2018 .
Dynavax announces that the FDA has accepted for review the company responses to the Nov 16 Complete Response Letter, and has therefore established a Prescription Drug User Fee Act action date of 10th Aug 2017 .
FDA issues a third complete response letter, prompting Dynavax to start looking for a partner. Dynavax attributed the complete response letter, in part, to the FDA´s inability to assess additional details it provided in October before the end of the review period. The details were submitted to allay FDA concerns about specific adverse events of special interest and an imbalance in the number of cardiac events seen in one trial of Heplisav-B. The FDA cited these concerns, as well as others relating to safety analyses and postmarketing commitments, in its CRL. The FDA requested no additional clinical trials, nor did it flag worries about autoimmune adverse events .
FDA extends the Prescription Drug User Fee Act (PDUFA) action date for Heplisav-B by three months to December 15, 2016. On the request of the FDA, Dynavax has submitted individual trial data sets that, which the FDA considers to be a major amendment to the BLA, so needing a full review .
Filed in the US for immunisation against hepatitis B infection in adults 18 years of age and older. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date .
EU filing withdrawn. The EMA Day 180 List of Outstanding Issues indicate that the current HEPLISAV safety database is considered to be too small to rule out a risk of less common serious adverse events. Dynavax expects to begin shortly an additional HEPLISAV trial, HBV-23, that is intended to provide a safety database sufficient to support licensure .
The Company is currently preparing its response to the EMA’s 120-day list of questions to be submitted in Q4 2013. It is likely that some issues will require clarification at the 180-day list .
The FDA had provided some fresh insights into the safety data it wants to see before it can approve Heplisav which will delay approval. The company are unlikely to file for restricted approval in patients with CKD .
US marketing application is rejected in a complete response letter from the FDA. The agency wants further evaluation of safety in the broad age group of 18 to 70 and expressed concerns over the possibility of rare autoimmune events associated with novel adjuvants. It also raised questions about process validation and manufacturing controls and facilities. It is possible that the FDA may approve the vaccine in a restricted group (CKD or >40 years of age) .
The FDA advisory panel voted 13-1 that data adequately demonstrated immunogenicity but voted 8-5 with one abstention that there was insufficient data to adequately support the safety of HEPLISAV .
EMA has accepted the filing for Heplisav, intended for immunisation of adults aged 18 to 70 years of age AND those with CKD .
The FDA Vaccines and Related Biological Products Advisory Committee will discuss HEPLISAV at its meeting on November 14-15, 2012 .
Filed in the EU for immunisation against infection caused by all known subtypes of hepatitis B virus in adults with chronic kidney disease .
FDA has accepted for review, HEPLISAV for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age. The company plan to file in the EU in the third quarter of 2012 .
Filed in the US for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 to70 years of age .
Dynavax plans to file in the US by mid-May for an indication in healthy adults 18-70 years of age for a 2-dose vaccination regimen at 0 and 1 month. A supplemental filing with an indication and 3-dose primary vaccination regimen for patients with CKD will be filed when the first indication is approved .
Company plan to file in US and EU early 2012 .