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November 19, 2013

Merck’s NDA for intravenous Noxafil gets FDA priority review status

Merck has received 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).

By admin-demo

Aspergillus

Merck has received 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).

The company has also submitted a marketing authorisation 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.

The priority review status is given to applications for drugs that, if approved, could offer significant improvements in the safety or effectiveness of treatment, diagnosis or prevention of serious conditions.

Noxafil oral suspension is currently being marketed by the company in the US for prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients 13 years of age and older who are at high-risk of developing these infections.

"The priority review status is given to applications for drugs that could offer significant improvements in the safety or effectiveness of treatment, diagnosis or prevention of serious conditions."

The immunocompromised patients include who have received haematopoietic 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, the company submitted NDA for an investigational, tablet formulation of Noxafil with both the FDA and European Medicines Agency (EMA), which are currently under review.

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According to the company, Noxafil is contraindicated in people 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 nine-fold and can result in sirolimus toxicity.

The company said that co-administration of Noxafil with rifabutin, phenytoin, efavirenz, cimetidine and esomeprazole should be avoided unless the benefit outweighs the risk.


Image: A micrograph of an aspergillosis infection. Photo: courtesy of Nephron.

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