PharmTechTalk blogger Patricia Van Arnum calls the FDA's recent approval of a supplemental biologics license application for Fluzone Intradermal a "step forward" for patient-friendly drug delivery. It's an influenza vaccine delivered through an ultra-fine needle that is 90 percent shorter than the typical needle used in intramuscular injection of a flu vaccine, according to Sanofi Pasteur, the vaccines division of Sanofi.
The Fluzone Intradermal vaccine uses a prefilled microinjection system that deposits vaccine antigens into the dermal layer of the skin. This layer contains a high concentration of dendritic cells, which play a key role in generating an immune response.
"Less invasive delivery methods, such as microneedle drug delivery, may present alternatives to make biopharmaceuticals an attractive option," Van Arnum writes. "Even though a biologic drug may offer an improved mechanism of action and clinical efficacy, that therapeutic advantage has to be balanced with how the drug is administered and delivered to gain patient acceptance and compliance."
While delivery methods are secondary considerations for difficult-to-treat diseases, she writes, patient-friendly methods need to be considered when large-molecule drugs are competing against orally administered small-molecule drugs. "As the pharmaceutical industry builds its biologic-based drug pipeline and with it, a product life-cycle management strategy, 'delivering the goods,' takes on a new level of importance," Van Arnum writes.
- read Patricia Van Arnum's blog post
- and here's the release on FDA approval of the Fluzone Intradermal vaccine