logo
Share SHARE
FONT-SIZE Plus   Neg

Dynavax Gets FDA Complete Response Letter On HEPLISAV - Quick Facts

Dynavax Technologies Corp. (DVAX: Quote) announced Monday that it received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its Biologic License Application or BLA for HEPLISAV, an investigational adult hepatitis B vaccine.

In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events. However, the Agency indicated its willingness to continue discussions regarding a more restricted use of HEPLISAV.

The company added that it plans to discuss the CRL with the FDA to identify the most expeditious path to approval for HEPLISAV, particularly in adults who may receive the greatest benefit from HEPLISAV.

In addition, the FDA requested additional data from Dynavax's process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product.

The company believes it can provide the information but the exact timeframe for its response cannot be determined until it has met with the Agency.

The company also plans to meet with the FDA to discuss the steps necessary for potential approval of HEPLISAV and currently believes the meeting can take place within 6 weeks.

Dynavax's BLA was accepted for review by the FDA in June 2012. On November 15, 2012, the FDA's Vaccines and Related Biological Products Advisory Committee (Committee) voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of HEPLISAV, although the Committee voted 13 to 1 that HEPLISAV data adequately demonstrated immunogenicity.

The company noted that its Marketing Authorization Application continues to be under review in Europe.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Internet giant Google Inc. (GOOGL, GOOG) has launched a new online flight search tool that makes it easy to find out the best flight deal. The tool dubbed "Google Flights" provides a calendar that one can scroll through and see the lowest fare highlighted for each day. One can also use the lowest... Hyperloop Transportation Technologies, a start-up that has adopted Elon Musk's ambitious project of high-speed transportation system, plans to build a Hyperloop test track in California and completed as early as 2016. Hyperloop Test Technologies, a crowd-funded company, plans to take Musk's dream... Colors have set the social media afire after an otherwise innocuous photo of a bodycon dress kept users guessing as to what hues permeate it. Opinions are divided, with some seeing the dress as white and gold, and others as blue and black. The photo was posted on Tumblr by a user called Swiked.
comments powered by Disqus
RELATED NEWS
Trade DVAX now with 
Follow RTT