What is the FDA's role in approving Sublingual Immunotherapy?

There is a great deal of confusion regarding sublingual immunotherapy and its approval status with the FDA.

The FDA regulates products and not the practice of medicine. The FDA establishes standardized guidelines (currently for 16 allergens), Good Manufacturing Practices (GMP) and ultimately approve biologic extracts. These extracts are used in for both injection and sublingual immunotherapy, however the package inserts for biologic extracts indicate their use for injection immunotherapy and skin testing. Use of these extracts in sublingual immunotherapy is an "off-label" use of biologic extracts.

As physicians, we commonly use medications in an off label manner if the level of scientific evidence is sufficient and the use fills an unmet need, which is the case with SLIT. For environmental allergies, meta-analyses have shown efficacy in allergic rhinitis and asthma in both adults and children. The level of evidence is now rated "1a" (the best rating possible). Because of the superior safety profile of SLIT (compared to SCIT), we believe it is an effective option— especially in patients who are not candidates for SCIT, such as young children.

There is the propensity in the marketplace to create a one-size-fits-all product, however, the patient-specific customized approach we feel best suits individual patients allows for ongoing assessment and dose adjustment based on the individual's response to treatment, a safer and more economical route. Patient treatment vials are individually customized at our practice and prepared under a physician's supervision in our on-site laboratory.

Phase III studies are underway for environmental single antigen products such as grass. These may be available in the U.S. in the next year or two.

While product approval is pending, allergists are currently able to prescribe sublingual immunotherapy for individual patients in an off-label manner, just as is done with a myriad of other medications.

 

 

Why offer Sublingual Immunotherapy to your patients?

two physicians talkingTreating an allergy's underlying cause is the focus of sublingual immunotherapy (SLIT), as compared to over-the-counter and prescription drugs which provide temporary relief from symptoms.

One out of five Americans suffer from allergies. For some, allergies are simply a short lived nuisance; however for millions they are a life altering disease. The only treatment that reprograms the overreacting immune system is immunotherapy, which involves gradual delivery of the substances that trigger allergies to acclimate the body to the world around it.

Currently in the U.S., an estimated three million people receive allergy immunotherapy. Most of these patients are seen by allergists and are treated with injection immunotherapy.

In other parts of the world, physicians are expanding the use of immunotherapy by introducing allergens to the body through the dendritic cells lining the mouth (oral mucosa). This method is referred to as sublingual immunotherapy. Up to 75% of allergy sufferers in southern Europe use antigen drops under the tongue for their allergy treatment. According to a recent review of over 20 European studies, patients who received allergy drops experience a 42% reduction in allergy symptoms and a 43% reduction in medication use in less than three years.

Through its safety profile, SLIT allows patients who are not candidates for injection immunotherapy, including children, highly reactive patients, asthmatics, and those with food allergies, to receive the benefits of immunotherapy. In our estimation, if those who could benefit from SLIT were under treatment, the current three million patients in immunotherapy would grow to 10 to 15 million.

Broader application, increased safety, ease of use, higher compliance and lower costs are all advantages of sublingual immunotherapy.