Pete,
Accutane is the current gold standard for efficacy with respect to severe acne. The problem with Accutane is that it has a terrible safety profile. One of the side effects is possible birth defects if taken by pregnant women.
The following paragraph from the FDA article I believe demonstrates that MBI 594AN, for severe acne, is a potential candidate for fast track approval.
"...Nonetheless, some adverse reactions are significant public health problems, and the development of therapies that do
not cause such serious reactions would merit close attention. The Agency may designate the development of such a therapy as a fast track drug development program when (i) currently accepted therapy is widely used despite an unavoidable serious risk, (ii) serious outcomes are a significant public health issue, and (iii) the new therapy shows significant potential to have a substantially improved overall safety profile with at least similar
efficacy..."
Lets hope the FDA agrees.
Sean
p.s. Here is the paragraph from the FDA article in its entirity.
e. A product that is intended, and is being studied for its ability, to treat a
condition while avoiding the side effects of currently accepted treatments
of the condition may be considered to treat a serious condition if such side
effects are serious (e.g., a less myelosuppressive treatment for a tumor or
an anti-inflammatory drug that does not cause gastrointestinal bleeding).
The potential for a new drug to avoid the serious sequelae of existing drugs
would qualify that drug development program for fast track designation
only in limited circumstances. Many therapies, even those intended to treat
non-serious conditions, are associated with rare, serious, adverse reactions,
and new therapies, despite initial hopes, often are associated with their own
set of serious reactions. Nonetheless, some adverse reactions are
significant public health problems, and the development of therapies that do
not cause such serious reactions would merit close attention. The Agency
may designate the development of such a therapy as a fast track drug
development program when (i) currently accepted therapy is widely used
despite an unavoidable serious risk, (ii) serious outcomes are a significant
public health issue, and (iii) the new therapy shows significant potential to
have a substantially improved overall safety profile with at least similar
efficacy.
Many conditions not generally considered to be serious have rare or distant serious
sequelae (e.g., urinary tract infections or duodenal ulcers). Product development
programs for such conditions could be designated as fast track if the sponsor specifically
designs the development program to demonstrate an effect on those serious sequelae.
Conversely, some conditions that are generally considered to be serious have non-serious
manifestations requiring symptomatic therapy (e.g., insomnia associated with
schizophrenia, skin discoloration from Addison?s disease, alopecia with lupus,
subcutaneous nodules from rheumatoid arthritis). The Agency will not generally designate
as fast track a development program for a product whose effect has been measured in
terms of non-serious manifestations unless the product?s effect on those manifestations is
reasonably likely to predict benefit on a serious manifestation.
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