December 22, 2020: Ridgeback Biotherapeutics LP, a biotechnology company experienced in antiviral drug development, announced today that the U.S.FDA approved EbangaTM for the treatment of Ebola.
Ebanga is now approved for treatment of infection caused by Zaire ebolavirus in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection).
Ebanga is the only FDA approved, single injection Ebola treatment which is available in a lyophilized form.
Wendy Holman, CEO and co-founder of Ridgeback, said: “I speak on behalf of the entire Ridgeback Bio team when I say thank you to all of the dedicated and thoughtful groups who helped contribute to this historic and important product approval.
Ridgeback is grateful to NIAID’s Vaccine Research Center (VRC) and the Democratic Republic of the Congo’s (DRC) Institut National pour la Recherche Biomédicale (INRB).
Specifically, the brilliance of three individuals needs to be acknowledged — Dr. Nancy Sullivan (VRC), Dr. John Mascola (VRC) and Professor Jean-Jacques Muyembe-Tamfum (INRB).
It was their mission to create a lyophilized single-use Ebola treatment, and in partnership with the team at Ridgeback, that vision became a reality.
We would also like to thank FDA leadership and the Ebanga review team at FDA’s Division of Antivirals (DAV) for their focused and thorough review of this product.
Finally, the true heroes are the patients and their families who allowed themselves to be carried away from their homes – not knowing if they would ever return – in order to enroll in a randomized controlled trial at the Ebola treatment centers during the 2018-2020 Ebola outbreak in the DRC.
Your trust and belief in science, innovation and the people caring for you has transformed Ebola forever. Thanks to you, Ebola is now a treatable disease.”
The efforts of the Pamoja Tulinde Maisha (PALM [“Together Save Lives” in the Kiswahili language]) study team conclusively demonstrated Ebanga’s safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history.
The PALM study team efforts represent a landmark achievement in the development of medical countermeasures for emerging infectious disease.
Wendy Holman added: “The devoted Ridgeback team embarked on this mission with one goal in mind – to stop the spread of Ebola and stop the devastation created by this aggressive disease.
The Ridgeback team has been tireless in their efforts, united in their mission and focused on bettering the lives of the patients we impact.
I am so thankful to this committed team and I look forward to how we can further our mission of helping people by serving unmet needs for those with grievous illness.”
Ridgeback will continue to make Ebanga available to patients who need it.
In 2020, Ridgeback initiated a compassionate use protocol for Ebola patients during the DRC’s 11th Ebola outbreak in Équateur Province.
Ebanga was provided to all PCR-positive Ebola patients under this protocol.
Dr. Sabue Mulangu, Senior Vice President of Global Affairs at Ridgeback, commented: “We were hopeful that news of an effective treatment would encourage patients with Ebola symptoms to present early in the disease course which should lead to even better outcomes for patients and less spread in the community.
We are looking forward to publishing the tremendous results of this effort in Équateur Province. In addition, we are working with at-risk African nations and non-government agencies to preposition Ebanga and insure access for patients.”
In conjunction with this approval, the Wayne and Wendy Holman Foundation has announced a newly funded program that will work to serve and support scientists and scholars from the DRC who wish to pursue advanced science degrees both in the DRC and abroad.
About Ebanga:
Ebanga™ (ansuvimab-zykl, formerly referred to as mAb114) is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC.
Nancy Sullivan, Ph.D., Chief of the Biodefense Research Section at the NIAID, VRC and her team, alongside scientists from VIR Biotechnology’s Humabs BioMed S.A. subsidiary, discovered that the survivor retained antibodies against Ebola 11 years after infection.
The team isolated the antibodies, tested the most favorable ones in both laboratory and nonhuman primate studies, and selected ansuvimab as the most promising among the set for clinical trial.
Professor Jean-Jacques Muyembe-Tamfum, Director General of DRC’s INRB and one of the scientists involved in the original detection of the Ebola virus in 1976, played a key role in discovering Ebanga.”
https://www.businesswire.com/news/home/20201222005421/en/Ridgeback-Biotherapeutics-LP-Announces-the-Approval-of-EbangaTM-for-Ebola
