dm+d

Unassigned

New Medicines

InmazebEbola virus infection - treatment

Information

Inmazeb
New molecular entity
Not Known
Regeneron

Development and Regulatory status

None
None
Approved (Licensed)
Yes
Oct 20Under a deal struck in July, Regeneron will deliver doses of the drug to the U.S. government over the next six years for outbreak preparedness. In return, the government will pay the company $10 million next year and an average of $67 million annually between 2022 and 2026. Further, with backing from the US Biomedical Advanced Research and Development Authority (BARDA), Regeneron will provide the Ebola drug to fight an outbreak in the Democratic Republic of Congo. The company is working with nonprofits and health authorities to enable access in low- and middle- income countries [8].
Oct 20FDA approves the first treatment, Inmazeb, to treat Zaire ebolavirus in adults and children [8].
Apr 20FDA accept filing of BLA for approval with priority review with a target action date of Oct 25, 2020. The drug was granted Breakthrough Therapy Status by the FDA in Nov 19 [6,7].
Jun 19In PIII development [4].
Oct 17Regeneron announce PI trial is now complete, and that they will receive approximately $40 million from the Biomedical Advanced Research and Development Authority (BARDA), a unit of the U.S. Department of Health and Human Services, for REGN3470-3471-3479 to support clinical investigation, a potential Biologics Licensing Application (BLA) and initial procurement of the therapy for the Strategic National Stockpile [1,2].
Apr 16Granted orphan drug status in the US [1]

Category

A fixed dose combination of three monoclonal antibodies, REGN 3470, REGN 3471 and REGN 3479 for the treatment of Ebola virus infection, using proprietary rapid response technologies [1].
Natural Ebola outbreaks occur most often in African countries, the most recent from 2014 through 2016. According to the World Health Organization, during that outbreak more than 28,600 cases of Ebola virus infection were suspected, probable or confirmed and more than 11,000 people died [2].
Ebola virus infection - treatment
Intravenous

Trial or other data

Oct 20Inmazeb binds to the glycoprotein on the surface of the Ebola virus and prevents it from entering cells. US approval was based on a trial conducted from 2018 to 2019 in the Democratic Republic of Congo. The study showed Inmazeb was better at reducing risk of death vs. other investigational drugs ZMapp from Mapp Biopharmaceutical and remdesivir from Gilead Sciences. The Ebola trial evaluated the medicines in 681 patients, and, in 2019, investigators stopped the trial early after a pre-specified interim analysis showed Inmazeb was better than the other meds at helping patients survive. Some patients on Inmazeb experienced fever, chills, vomiting and faster heart rate and breathing, but the FDA noted those are also symptoms of Ebola infections [8].
Jun 19PIII trial (NCT03719586) is recruiting in the US & Democratic Republic of Congo. The trial started in Dec 18 and 550 participants will be randomly assigned to get 1 of 3 study drugs: ZMapp by IV over about 4 hours (given 3 times, 3 days apart; remdesivir by IV over about 1 hour (once a day for 10 days); Mab114 by IV for 30-60 minutes (single dose) and REGN-EB3 by IV for about 2 hours (single dose). The trial is expected to complete collection of primary outcome data (death rate) in Nov 23 [5].
May 16PI randomised, double-blind, placebo-controlled, single ascending dose study investigating the safety, tolerability, and pharmacokinetics of IV REGN3470-3471-3479 in healthy adult subjects (NCT02777151) began recruiting, with primary outcome measure of incidence and severity of treatment emergent adverse effects (TEAEs) from baseline up to day 169. Estimated primary completion date is May 17 [1,3].

Evidence based evaluations