The ID Pipeline: FDA Activity From the Week of January 26, 2020
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 26, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 26, 2020.
FDA Approves Fidamoxicin for Pediatric C diff
The US Food and Drug Administration (FDA) has approved fidamoxicin (Dificid) for the treatment of children aged 6 months up to 18 years with Clostridiodies difficile (C diff) infections. Additionally, fidamoxicin has also been approved for oral suspension. The approvals were granted to Merck.
Fidamoxicin is a macrolide antibiotic active against gram-positive bacteria.
Read the full story here.
Phase 2 Trial Begins For DNV3837 C diff Antibiotic
Deinove has announced the inclusion of the first patient in the Phase 2 trial of DNV3837.
DNV3837 is an intravenous antibiotic which is converted to an active form called DNV3681. It then crosses the gastrointestinal barrier and accumulates in the intestinal lumen, allowing targeting of the infection site.
The trial will take place primarily in 15 centers in the United States, starting with a cohort of 10 patients who have moderate to severe C diff infections. Then, a randomized cohort study testing the antibiotic against standard of care in 30 patients with severe C diff infection will take place.
Read the press release here.
NIAID Launches Malaria Monoclonal Antibody Trial
In 2018, scientists discovered a human antibody which protected mice from the malaria-causing Plasmodium falciparum parasite.
Now, a phase 1 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutues of Health, has begun enrolling healthy adult volunteers. The study will test the safety and effectiveness of monoclonal antibody CIS43LS (mAb CIS43LS) used as prophylaxis against malaria.
Read the full story here.
