I spoke too soon about the Mycograb Med

[Guest guest]

Quality, safety issues block Novartis' antifungal approval

(http://www.in-pharmatechnologist.com/Processing-QC/Quality-safety-

issues-block-Novartis-antifungal-approval)

(http://tiny.cc/9cmRT)

27-Nov-2006 - Leading drug manufacturer Novartis is set to appeal

following failure to gain approval for their anti-fungal treatment

Mycograb in the European Union.

The Committee for Medicinal Products for Human Use (CHMP) recommended

that the company be refused marketing authorization for Mycograb

(efungumab) following concerns over the quality and safety of the

medicine.

Mycograb is intended for use in combination with amphotericin B for

treatment of serious systemic fungal infections, primarily cases of

invasive candidiasis in adults. However, despite its superior

efficacy when compared to treatment with amphotericin B alone (the

most common treatment option for such infections), the CHMP was

reluctant to approve the drug.

While Novartis state that they are confident of gaining approval for

Mycograb, the CHMP raised concerns regarding the folding and

aggregating of Mycograb, and the possibility of immune responses in

some patients.

In addition to this, potential cases of cytokine release syndrome (a

potentially life-threatening condition characterised by fever, chills

and hypotension) were cited as another concern for the use of

Mycograb, although the cause of this was unknown. Amphotericin B has

however also been implicated in inflammatory cytokine response.