Over a million people each year in the US alone are hospitalised with pneumonia, and treated with antibiotics delivered via the bloodstream (by injection or tablet).
The federal Task Force on Antimicrobial Resistance has identified pneumonia as one of the areas of greatest antimicrobial drug exposure, and has a specific objective of combating the threat of antimicrobial resistance by reducing the use of antibiotics.
A recent observation by Lewis hints at a major problem which has been allowing bacteria time to develop resistant strains -
"IV amikacin is used to treat this patient population right now. You can't get enough amikacin into the lung through IV to successfully address this disease"
For me, all that could ever have realistically prevented Insmed from owning the treatment of pulmonary disease with its inhaled liposome delivery was the possibility of a major safety issue. That uncertainty seems to have been addressed -
From the 10-K -
1. "When rats were given ARIKACE daily by inhalation for two years, 2 of the 120 rats receiving the highest dose had a single lung tumor. These rats received ARIKACE doses that were within two-fold of those in clinical studies (normalized on a body surface area basis or a lung weight basis)."
2. "As agreed with the FDA, an unaudited interim report of the findings from the first group of dogs that completed 9 months of dosing was recently submitted to the FDA. In summary, this report stated that the lung macrophage response in the first group of dogs was similar to that seen in our previous 3 month dosing dog study, and there was no evidence of neoplasia, squamous metaplasia or proliferative changes."
There is nothing there which would suggest a safety concern with the relatively brief period of exposure associated with a typical course of antibiotics.
The federal task force NEEDS all of the antibiotics currently used to treat pulmonary infection to be converted to inhaled liposome delivery sooner rather than later.
A new report, published online on April 18 in Clinical Infectious Diseases, says that there are only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli.
There's no guarantee that any of those seven drugs will survive the clinical trial process. Assuming that one or more do make it, there's no guarantee that they will have the potential to control the increase in drug resistance in the pathogens considered likely by public health authorities worldwide to pose the most serious threat to public health.
Organisations such as the federal Task Force on Antimicrobial Resistance and the Transatlantic Taskforce on Antimicrobial Resistance will not have formulated strategy dependent upon the approval of any of those seven new drugs. And with no hope of the cavalry arriving any time soon, a far more effective way of using the drugs already available would seem an answer to their prayers.
Satltsasw (pretending he didn't acknowledge my explanation of this very same point only yesterday) points out again that Insmed hasn't mentioned pneumonia. As I reminded Satltsasw yesterday, nobody at Insmed will say anything which could be construed as promoting the unapproved use of a drug. Lewis will only promote the current Arikace program.
But as Bo has pointed out, the new suggestion that Insmed will operate "at the intersection of orphan drugs, pulmonary diseases and anti-infective therapies" was interesting. As indeed was the recent observation that the original plan for Arikace was an application for approval under the 505(b)(2) pathway.
Had the FDA allowed that pathway, Arikace would have been approved for the treatment of pulmonary conditions for which injected amikacin is already approved - "serious infections due to susceptible strains of Gram-negative bacteria".
Satltsasw will doubtless point out that there is no mention of pneumonia.
Btw - I see that Rehdvm is unaware of the spectrum of activity of amikacin.
On the subject of sad attempts by charlatans, this latest contribution is in the running for the most pathetic attempt at deceit with which we've ever been insulted -
"Pneumonia is different from lung infection. Pneumonia has exudate and "junk" in the alveoli and airways. The antibiotic has to penetrate into mass and the exudate and "junk" has to be cleared from the lungs. Infection (like what Arikace is used to treat) is just bacterial living in the biofilm and macrophages. There is no significant amount of debris to be cleared."
It beggars belief that Rehdvm is so arrogant as to misrepresent pseudomonas infection in Cystic Fibrosis as a simple infection where "there is no significant amount of debris to be cleared." The truth is that CF offers a perfect example of his description of pneumonia. Rehdvm is effectively arguing that compelling results from the EU CF clinical trial will be strongly supportive of the use of Arikace in the treatment of pneumonia.
If Satltsasw was a separate individual with any real intelligence he would mercilessly expose Rehdvm's dishonesty and stupidity. But don't hold your breath - the same wannabe shyster owns both of those ids.
It's well worth noting that due to the speed at which inhaled therapeutics usually transfer from the lungs into the bloodstream, there are significant dosage limitations associated with the use of currently inhaled aminoglycosides such as amikacin and tobramycin.
Ignore the sad attempts to deceive by charlatans with hidden agendas. Check out the clinical trial record for the proposed Korean study of inhaled amikacin as a therapy for NTM - finally refused on the grounds of safety. One suspects that the organizers of the proposed Nektar/Bayer study will be first want to see the results from the Arikace study before deciding whether or not to proceed.