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FDA approves Ragwitek, first SLIT agent for ragweed allergies
The FDA has approved the third sublingual immunotherapy tablet this month, according to a press release.
Ragwitek (Ambrosia artemisiifolia extract, Merck) sublingual immunotherapy (SLIT) tablets are indicated for the treatment of short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis in adults aged 18 to 65 years.
Karen Midthun
“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
In January, the FDA Allergenic Products Advisory Committee voted 8 to 0, with one abstention, regarding the drug’s safety data, and 6 to 2, with one abstention, in favor on Ragwitek’s efficacy.
As with other SLIT agents, the first dose would be administered at a doctor’s office, beginning 12 weeks before the start of ragweed pollen season and continued throughout the season.
In clinical trials, Ragwitek was assessed in approximately 1,700 adults. The most commonly reported adverse events included pruritus of the mouth and ears, and throat irritation. Patients who received Ragwitek experienced approximately a 26% reduction in symptoms and the need for medications compared with those who received placebo, according to the press release.
Greer/Stallergenes received approval for its grass pollen SLIT agent, Oralair earlier this month; followed by Merck’s Grastek.
For more information:
FDA Briefing Document. Biologics License Application (BLA) for Ragwitek [Standardized Allergen Extract, Short Ragweed (Ambrosia artemisiifolia)] sublingual tablet for oral use.
Perspective
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The recent FDA approval of the oral tablet immunotherapy for grass allergy, Grastek and Oralair, and for ragweed allergy, Ragwitek, mark a significant step forward in available treatment options for pollen allergy sufferers. The tablets will be especially helpful for people with mild to moderate seasonal allergies not well controlled by pharmaceutical options, like antihistamines and intranasal steroid sprays. For the great majority of allergy sufferers with moderate to severe symptoms, grass and ragweed are just two of many offending allergens. Unlike subcutaneous immunotherapy, tablets cannot be customized to treat multiple allergens. The FDA approval also recommends that patients be evaluated by an allergist/immunologist before being started on the new tablets, as seasonal allergies can also be triggered by other allergens such as outdoor mold. Even dust mite allergies can be seasonal due to humidity swings.
Perspective
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Ragweed is the one pollen that has the longest pollen season and accounts for greatest number of pollen allergic people east of the Rocky Mountains. For this reason, it is a welcome addition. It is not as effective as allergy injections but in those allergic only to ragweed it may be worth a try. If it fails, seeing an allergist is probably important to ensure patients are truly ragweed allergic and not allergic to the mold spores which are high at the same time or that patients are allergic to many things.
Perspective
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The approval of Ragwitek for the treatment of seasonal allergies to ragweed will be a nice addition to our current treatment options for this patient population (ragweed allergy patient with nasal and ocular symptoms).
As you know, Ragwitek is only indicated for patients with seasonal nasal and ocular symptoms from ragweed and is not an indicated treatment option for patients who have seasonal ragweed asthma. In my opinion, this will be a nice potential treatment option for those patients who are only ragweed allergic and not controlled on nasal steroids and/or antihistamines. This will not be a treatment options for patients with multiple other allergic triggers (ie, patients with concomitant allergy to dust mites, molds, animal and/or other pollens).
There are some limitations to this treatment in that it must be started weeks prior to the onset of the ragweed season and there is a risk for life threatening reactions that the patient must be educated in and be prepared to self-treat with injectable epinephrine if a serious reaction were to occur.
This new therapy will not replace traditional subcutaneous immunotherapy, as many allergy patients have complicated multi-seasonal sensitivities and allergic diseases for which subcutaneous immunotherapy would be more appropriate.
In summary, Ragwitek is a positive addition to our treatment options for patients with allergic disease but, as with any medication, must be used by physicians experienced in diagnosing and managing these diseases so that the correct patient is chosen for optimal outcomes.