EU orphan status for Nektar's ABIP

US firm Nektar Therapeutics says that its Amphotericin B Inhalation Powder (ABIP) product has been granted Orphan Medicinal Product designation by the European Commission for the prevention of pulmonary fungal infections in patients deemed at risk. This designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).

"Prevention of these serious fungal infections in the lung is a major priority, given the increasing incidence of invasive pulmonary aspergillosis in immunosuppressed patients," said David Denning, professor of medicine and medical mycology at the University of Manchester, UK. "Any therapy that reduces the incidence of invasive pulmonary aspergillosis in particular is welcome, as these infections are frequently fatal, and can be expensive to treat," Dr Denning added.

In the USA, the Food and Drug Administration has granted both fast-track and orphan status for Nektar's ABIP for the prevention of pulmonary fungal infections in patients at risk of aspergillosis due to immunosuppressive therapy, the company noted.