Tuesday, 4 May 2010

Inhalable Amphotericin Powder get the Green Light from FDA

Amphotericin B Inhalation Powder (ABIP) have been granted fast track designation by the American Food and Drug Administration (FDA). The FDA are responsible for the safety of all drugs on the US market and their actions are often a precurser for drug availability across the rest of the world.

Amphotericin is an antifungal with a long history of use against aspergillosis - originally develped in the 1950's (we have written about it several times). It can be very effective against aspergillus but has long suffered from a major weakness - it is poorly soluble in water. This means that it couldn't be taken orally and that it had to be dissolved in a quite toxic substance that tends to give a lot of side effects. A pair of drugs emerged that were based on Amphotericin but which were prepared in a different way for intravenous use. These were very sophisticated drugs that were very expensive to use (i.e. Amphocil and Abelcet) and so had limited application.

There have been a series of new drugs based on Amphotericin coming out over the last year or two, several of which have been reported in this blog e.g. oral Amphotericin and aerosolised Amphotericin. A recent report demonstrated some success in the use of inhalable Amphotericin to provide prophylactic protection for a group of patients who are at high risk from Aspergillus infection, and who would be very difficult to treat if that infection took hold.

Success in the prevention of fungal infection for transplant patients clearly has had some impact and this new form of Amphotericin - a powder designed to be inhaled - has been made available for exactly that purpose and for other immunocompromised patients.

"Fast Track designation allows the FDA to expedite the review of new drugs that are intended for serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs."
 Dr. David Johnston, Nektar senior vice president of research and development made the following hopeful comment:
“Our product could represent a major paradigm shift in antifungal therapies as we aim to prevent infections by targeting the lungs directly and therefore avoid the serious systemic and dose-limiting side effects of intravenous and oral therapies." 
As ever, time will tell whether or not this comment is valid.

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