Merck Sharp and Dohme passes regulatory milestones for intravenous Noxafil

Merck Sharp and Dohme has highlighted the progress it has made with its regulatory filings for its investigational intravenous solution formulation of the the antifungal agent Noxafil.

The US Food and Drug Administration (FDA) has granted the new product priority review status, which is assigned to therapies that could provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

A marketing authorisation application for intravenous Noxafil has also been submitted to the European Medicines Agency, with further approvals set to be sought in other countries.

Noxafil is currently marketed as an oral suspension for the prevention of invasive Aspergillus and Candida infections among patients who are at high risk due to a weak immune system.

Additionally, the company filed for US and EU approval of an investigational tablet version of the therapy earlier this year, with these applications still under review.

Merck Sharp and Dohme also announced positive data from a phase Ib trial of its new immunotherapy MK-3475 this week, showing the drug's potential as a means of combating melanoma.