The ID Pipeline: FDA Activity From the Week of October 6, 2019
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 6, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 6, 2019.
FDA Clears Marketing for First Rapid Diagnostic Test for Ebola Antigens in the US
On Thursday, October 10, 2019, the FDA announced approval allowing the marketing of a rapid diagnostic test to detect Ebola virus antigens in human blood.
The OraQuick Ebola Rapid Antigen test is able to detect the virus antigens in samples of blood from certain living individuals, as well as from deceased individuals suspected to have died from Ebola.
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the US Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC),” acting FDA Commissioner Ned Sharpless, MD, said in a statement. "The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”
The full press release is available here.
Phase 1 Trial of Equine Encephalitis Vaccine Underway by Bavarian Nordic
On Tuesday, October 8, 2019, Bavarian Nordic announced the initation of a phase 1, first-in-human clinical trial of its equine encephalitis vaccine candidate, MVA-BN® WEV.
The prophylactic vaccine prevents against 3 separate strains—Eastern (EEEV), Venezuelan (VEEV), and Western (WEEV). The trial seeks to evaluate the safety, toelrability, and immunogenicity of MVA-BN WEV in 45 healthy adults. Topline results are expected in 2020.
“After the recent FDA approval of our smallpox vaccine, which was developed in collaboration with various US government agencies and has become an integral part of the national stockpile, we are excited to advance this new program, helping to fulfil the US government’s goal to develop a broad range of medical countermeasures to protect US citizens,” Paul Chaplin, president and chief executive officer of Bavarian Nordic, said in a statement. “The prevalence of Eastern equine encephalitis, which is currently on the rise in the U.S., highlights the importance of a vaccine to help fight these diseases. Again, we are leveraging the unique properties of our MVA-BN platform technology to address unmet medical needs, and we look forward to continuing our work with DOD on this important program.”
The program is funded by the United States Department of Defense Joint Project Manager for Chemical, Biological, Radiation, and Nuclear Medical.
The full press release is available here.
Matinas BioPharma Receives Orphan Drug Designation for Cryptococcosis Treatment MAT2203
On Monday, October 7, 2019, the FDA granted orphan drug designation to Matinas BioPharma Holdings, Inc. for MAT2203, the company's proprietary oral amphotericin B product for the treatment of cryptococcosis.
MAT2203, an orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, is currently in phase 2 clinical development. The FDA previously granted QIDP status with Fast Track designation for 3 additional indications, including the prevention of invasive fungal infections due to immunosuppressive therapy, the treatment of invasive candidiasis, and the treatment of invasive aspergillus.
“Orphan drug designation is yet another major step forward for MAT2203 in the treatment of life-threatening fungal infections, and adds to the prior Qualified Infectious Disease Product (QIDP) and Fast Track designations this product has already received,” Theresa Matkovits, PhD, chief development officer of Matinas, said in a statement. “We believe MAT2203 represents a promising new approach for the treatment of severe fungal infections and addresses one of the most important limitations of current antifungal treatment options. Adding orphan drug designation to the QIDP for the treatment of cryptococcal meningitis potentially positions MAT2203 for up to 12 years of marketing exclusivity, if approved.”
The full press release is available here.
