The ID Pipeline: FDA Activity From the Week of January 5, 2020
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 5, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 5, 2020.
Meissa Receives FDA Fast Track Designation for MV-012-968 Respiratory Syncytial Virus Vaccine
Meissa Vaccines has announced that the FDA has granted fast track designation status to MV-012-968. MV-012-968 is an investigational, live attenuated vaccine for protection against respiratory syncytial virus infection.
Fast Track Designation will allow Meissa to interact with FDA reviewers frequently in order to develop a plan for the vaccine, and may also allow for Biologics License Application review under an expedited time frame if certain criteria are met.
Read the full press release here.
PDUFA Date Set for Resubmission of Intravenous Contepo
Nabriva Therapeutics has annoucnbed that the FDA has acknowledged receiving the new drug application resubmission for fosfomycin for injection (Contepo), for the treatment of complicated urinary tract infections.
In the acknowledgement letter from the FDA, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter issued by the FDA on April 30, 2019. Therefore, the FDA has set a new Prescription Drug User Fee Act goal date of June 19, 2020 for review of the new drug application.
Read the full press release here.
End of Phase 2 Meeting Announced for Chikungunya Vaccine Candidate
Valneva SE announced that an end of phase 2 meeting has been scheduled with the FDA for February 24, 2020, for its single-shot chikungunya vaccine candidate, VLA1553.
The firm intends to present plans for phase 3 clinical studies and licensure. The vaccine candidate was previously awarded fast track designation and may be eligible for priority review.
Read the full press release here.
FDA Approves Micafungin Injection for Use in Pediatric Patients
The FDA approved a supplemental new drug application for micafungin for injection (Mycamine).
The approval grants authorization for the product to be used to treat candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination in pediatric populations under 4 months of age. The approval was granted to Astella Pharma Inc.
The product is an echinocandin which has previously been approved for use in adult and pediatric patients. It inhibits and enzyme essential for fungal cell wall synthesis and is fungicidal for Candida.
Read the full article here.
