Resistance to echinocandin-class antifungal drugs
. Drug Resist Updat.
This approval also marks the second time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs
, a pathway, advanced by Congress, to spur development of drugs targeting infections that lack effective therapies.
Food & Drug Administration (FDA) for treating some of the most drug-resistant forms of tuberculosis (TB).A The new drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs
(LPAD pathway) as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive (collectively "highly drug-resistant TB").
CorMedix announced that Phoebe Mounts, EVP and general counsel, presented at a public meeting on July 12, 2019 hosted by FDA discussing the Limited Population Pathway for Antibacterial and Antifungal Drugs
. In her presentation, Dr.
Currently, only three major classes of clinical antifungal drugs
Following the passage of the limited population pathway for antibacterial and antifungal drugs
established by the 21st Century Cures Act the FDA can now grant approval for some anti-infective products on the basis of limited clinical data.
auris is often resistant to major antifungal drugs
that are typically used to treat such infections.
In vitro antifungal activity of topical and systemic antifungal drugs
against Malassezia species.
Arikayce (amikacin liposome inhalation suspension) is the first drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs
, or LPAD pathway, established by Congress under the 21st Century Cures Act.
Arikayce is the first medication approved under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs
, or LPAD pathway, which encourages development and approval of antibacterial and antifungal drugs
to treat certain serious or life-threatening infections.
Data regarding costs of antifungal drugs
, hospital, and ICU stay were provided by each participant hospital for each patient.
Meanwhile an increase in the emergence of new pathogenic species difficult to diagnose and treat has been observed (Coleman et al., 2008); this increase is not only due to the frequent use of antifungal drugs
to treat these kinds of infections but also due to therapeutic drug overdose.