With all eyes on their Covid-19 drug, Regeneron wins a landmark approval in Ebola
For the first time, the FDA has approved a therapy for Ebola, handing a landmark OK to Regeneron at the same moment that the New York biotech awaits word from the agency on a similar drug they developed for Covid-19.
Regeneron developed the drug, a cocktail of 3 neutralizing Ebola antibodies now known as Inmazeb, during the 2014-2016 West African outbreak, and when cases rose again in the DRC in 2018, the NIH selected it as one of four drugs to be tested in a large, first-of-its-kind clinical trial. The study was halted 12 months later after two drugs showed overwhelming efficacy. About a third of Ebola patients who received the Regeneron drug died, compared with just over 50% for the antibody ZMapp.
Alongside the approval of Merck’s Ebola vaccine, the drug was a huge pharmaceutical achievement and public health victory against a disease that doctors have struggled to treat or prevent since it was first identified in 1976. But it also quickly proved to be a test run for Regeneron’s next antiviral program, as they embarked barely 5 months later on building a similar cocktail of neutralizing antibodies for what was then known simply as the novel coronavirus.
BARDA has heavily supported both programs. Regeneron co-founder and CSO George Yancopoulos highlighted the similarities in his statement on the approval, echoing previous comments from Anthony Fauci and other scientists.
“This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” Yancopoulos said. “As we apply the same sophisticated technologies and manufacturing capabilities against COVID-19, we hope this will be one of many demonstrations of how the power of science can be successfully deployed against dangerous infectious diseases.”
Regeneron announced their first batch of human data for the Covid-19 therapy late last month and soon thereafter found themselves in the national spotlight when White House doctors decided to give a newly-diagnosed President Trump a high dose of the antibody cocktail. Trump subsequently promised an EUA for the therapy and a similar one in development with Eli Lilly, touting them as “like a cure” and a “miracle.” The FDA is still reviewing Regeneron’s application.
There is, of course, no ordinary market for an Ebola drug, particularly not in the US. But BARDA has already agreed to purchase an undisclosed number of doses of the drug for $10 million in 2021 and $67 million over the following 5 years. The treatment has also been used in the current DRC outbreak under compassionate use.
“Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company added in a statement.
In exchange for successfully bringing an Ebola drug to market, Regeneron will receive a priority review voucher, which they can use to accelerate FDA review or sell to another company. These vouchers can fetch upwards of $50 million on the open market; Sanofi once spent $245 million to acquire one.
The other drug that proved effective in the large Ebola study, a single antibody discovered with technology now owned by the GlaxoSmithKline-partnered Covid-19 developer Vir, is also now sitting before the FDA. It is owned by Ridgeback Therapeutics, a tiny Florida-based biotech.
Mapp Biopharmaceuticals, the company that developed and produced ZMapp, has discontinued the drug.