Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole),
Additionally, the company has also submitted a marketing authorization application to the European Medicines Agency (EMA) for Noxafil IV solution and intends to seek regulatory approval for the IV formulation in other countries worldwide.
Currently, the Noxafil oral suspension is being marketed by the company in the US for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised.
The immunocompromised patients include who have received hematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts (neutropenia) as a result of chemotherapy.
In April 2013, the company had submitted NDA for an investigational, tablet formulation of Noxafil with both the FDA and European Medicines Agency (EMA), which are currently under review.
According to Merck, Noxafil is contraindicated in persons with known hypersensitivity to posaconazole, any component of Noxafil, or other azole antifungal agents.
It is contraindicated with sirolimus, which increases the sirolimus blood concentrations by about nine-fold and can result in sirolimus toxicity.
The drug is also indicated with CYP3A4 substrates pimozide and quinidine, HMG-CoA reductase inhibitors as well as with ergot alkaloids.
According to the company, co-administration of Noxafil with rifabutin, phenytoin, efavirenz, cimetidine and esomeprazole should be avoided unless the benefit outweighs the risk.
