Biologics

FDA Rejects Dynavax BLA on Heplisav-B

FDA has sent Dynavax Technologies a Complete Response Letter (CRL) on its BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The letter seeks clarification about “specific adverse events of special interest” (AESIs), and a numerical imbalance in a small number of cardiac events in a single study, according to the company. It also asks for new analyses of the integrated safety data base across different time periods, and post-marketing commitments. “In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events,” the company says.

“The CRL is consistent with our opinion that Heplisav-B is approvable and we are seeking to meet with the FDA as soon as possible,” Dynavax says. “However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma.”

In 2013, the agency issued Dynavax a CRL on the BLA, which specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group, according to the company. “The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events,” it said at the time. In 2012, FDA’s Vaccines and Related Biological Products Advisory Committee voted (13 to 1) that the vaccine adequately demonstrated immunogenicity. However, the panel voted 8 to 5 with one abstention that there were insufficient data to adequately support the product’s safety.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome