- Dynavax Technologies reported to the SEC it is working to resolve remaining questions cited by the Food and Drug Administration over its previously rejected experimental hepatitis B vaccine despite the agency cancelling an advisory committee meeting.
- The Berkeley CA-based company will meet on its Biologics License Application to enable the FDA to complete its scheduled review by the previously proposed Prescription Drug User Fee Act (PDUFA) action date of Dec. 15.
- The FDA’s cancelation of the advisory committee meeting — originally scheduled for November — and the confirmed PDUFA date are conveying mixed signals to investors, causing the stock to take a roller coaster ride over the last month.
While the FDA’s action to postpone and not yet reschedule an advisory committee meeting on Dynavax’s proposed Heplisav-B vaccine may seem procedural, history shows it may be a signal of the end for the troubled-drug application. No one knows for sure, but this much is clear: there has been plenty of back-and-forth between Dynavax and the FDA, with the agency continually prodding and asking for more information.
An analyst review of when the FDA cancels previously scheduled advisory panel meetings, the agency’s most frequent next decision is the rejection of the drug under review, according to The Street. The analyst examined advisory committee meetings through 2008-2009 and found 15 instances where the FDA canceled a previously scheduled advisory panel meeting. In 13 of 15, FDA later rejected the drug.
Still, the company is moving ahead with high hopes for Heplisav-B, counting on a still-scheduled Dec. 15 meeting on a Prescription Drug User Fee application related to the drug. The FDA had extended its review of Dynavax by three months after the company resubmitted a BLA and additional data to the FDA in April in response to an FDA request.
Uncertainty is wrapped around the vaccine originally submitted to the FDA in 2013 and later rejected due to insufficient safety data.
Dynavax’s hopes for the vaccine rest in results of Phase 3 trials, where Heplisav-B demonstrated higher and earlier protection with fewer doses than the current licensed hepatitis B vaccine. The company notes that an effective vaccination is critical to reducing the spread of the disease.
In its SEC filing, Dynavax reported that it received "anticipated requests for information" from the FDA in connection with the BLA.
Dynavax said it is prepared to address the questions expeditiously to enable the FDA to complete its review. "The review team’s questions are in line with the company’s expectations," the company said in the SEC document.
Dynavax’s vaccine is for hepatitis B, a contagious viral disease of the liver that can lead to cirrhosis, hepatocellular carcinoma and death. There is no cure for the disease that impacts about 20,000 hepatitis B infections occur annually in the U.S., according to the Centers for Disease Control and Prevention.