FDA Approves Merck’s RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
Sublingual Tablet as Immunotherapy to Treat Short Ragweed Pollen-Induced
Allergic Rhinitis with or without Conjunctivitis in Adults
RAGWITEK is the First and Only FDA Approved Sublingual Allergen Immunotherapy
Tablet Indicated for the Treatment of Short Ragweed Pollen Allergies
WHITEHOUSE STATION, N.J. -- April 17, 2014
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today
announced that the U.S. Food and Drug Administration (FDA) has approved
RAGWITEK™ (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use
(12 Amb a 1-U). RAGWITEK is an allergen extract indicated as immunotherapy for
the treatment of short ragweed pollen-induced allergic rhinitis with or
without conjunctivitis confirmed by positive skin test or in vitro testing for
pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved
for use in adults 18 through 65 years of age. RAGWITEK is not indicated for
the immediate relief of allergic symptoms.
The prescribing information for RAGWITEK includes a boxed warning regarding
severe allergic reactions. RAGWITEK is contraindicated in patients with
severe, unstable or uncontrolled asthma; a history of any severe systemic
allergic reaction; a history of any severe local reaction after taking any
sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or
hypersensitivity to any of the inactive ingredients contained in the product.
"RAGWITEK provides a new sublingual approach to allergen immunotherapy for
adult patients suffering from moderate to severe ragweed pollen allergies who
have declined allergy shots," said Dr. David Skoner, director, Division of
Allergy and Immunology, Allegheny Health Network, and a clinical investigator
in Merck's sublingual allergen immunotherapy tablet program. "While there are
regional variations, ragweed season typically starts in mid-August across the
United States. During the season, many patients with moderate to severe
allergic rhinitis experience nasal and ocular allergy symptoms at their worst
while taking symptom-relieving medication. These patients often have multiple
sensitivities. To help prepare for the upcoming ragweed season, I would
encourage patients diagnosed with ragweed pollen allergies to make an
appointment now with an allergy specialist to discuss options."
Symptoms of short ragweed pollen-induced allergic rhinitis with or without
conjunctivitis may include sneezing, a runny or itchy nose, stuffy or
congested nose, or itchy and watery eyes, and typically intensify during the
ragweed pollen season.
“The FDA approval of RAGWITEK brings an important new option for allergy
specialists treating adults with allergic rhinitis with or without
conjunctivitis caused by short ragweed pollen,” said Dr. Sean Curtis, vice
president, Respiratory and Immunology, Merck Research Laboratories. “Merck is
proud to add this second sublingual allergen immunotherapy tablet to our
About short ragweed pollen allergy
While regional variation exists, in many areas of the United States ragweed
pollen season occurs from August to November. Ragweed pollen levels usually
peak in mid-September in many parts of the country.
Dosing and administration of RAGWITEK (Short Ragweed Pollen Allergen Extract)
The recommended dose of RAGWITEK is one tablet daily to be placed under the
tongue, where it will dissolve.
The first dose of RAGWITEK should be administered in a healthcare setting
under the supervision of a physician with experience in the diagnosis and
treatment of allergic diseases. The physician should observe the patient for
at least 30 minutes after receiving the first dose of RAGWITEK to monitor for
signs or symptoms of a severe systemic or a severe local allergic reaction. If
the patient tolerates the first dose, the patient may take subsequent doses at
home. The physician should prescribe auto-injectable epinephrine, and instruct
and train the patient on its appropriate use.
Initiate RAGWITEK at least 12 weeks before the expected onset of ragweed
pollen season and continue throughout the season. The safety and efficacy of
initiating treatment in season have not been established.
RAGWITEK will be available in U.S. pharmacies by the end of April.
About the clinical study program for RAGWITEK (Short Ragweed Pollen Allergen
The efficacy of RAGWITEK was supported by two Phase 3 clinical studies over a
single ragweed pollen season in patients 18 through 50 years of age. In both
randomized, double-blind, parallel group, multi-center studies:
*Patients had a history of short ragweed pollen-induced allergic rhinitis
with or without conjunctivitis, and sensitivity to short ragweed confirmed
by positive skin test or in vitro testing for pollen-specific IgE
antibodies for short ragweed;
*Patients with non-ragweed sensitivities were included as long as the
patients did not require treatment as a result of symptoms from those
non-ragweed allergies during the ragweed season;
*RAGWITEK or placebo was administered as a sublingual tablet and initiated
approximately 12 weeks before the start of the ragweed pollen season;
*Patients in both arms of the study were allowed to take symptom-relieving
medications (including systemic and topical antihistamines, and topical
and oral corticosteroids) as needed;
*Efficacy was established by self-reporting of rhinoconjunctivitis daily
symptom scores (DSS) and daily medication scores (DMS), the sums of which
were combined into the total combined score (TCS);
*Daily rhinoconjunctivitis symptoms included four nasal symptoms (runny
nose, stuffy nose, sneezing and itchy nose), and two ocular symptoms
(gritty/itchy eyes and watery eyes).
The FDA criteria for clinically relevant efficacy of allergen immunotherapy is
based on the TCS, which must have an average difference relative to placebo of
less than or equal to -15 percent, and the upper bound of the 95 percent
confidence interval (CI) must be less than or equal to -10 percent.
The first study compared RAGWITEK (n=187) relative to placebo (n=188) in
patients 18 through 50 years of age of whom approximately 22 percent had mild
asthma of a severity that required, at most, a daily low dose of an inhaled
corticosteroid, and 85 percent were sensitized to other allergens in addition
to short ragweed. Patients treated with RAGWITEK had significant reduction of
nasal and ocular symptoms, and reduction in use of symptom-relieving allergy
medication, as measured by a decrease in the TCS for the peak ragweed pollen
season, compared to placebo; difference of RAGWITEK (n=159) relative to
placebo (n=164) was -26 percent (95% CI: -38.7%; -14.6%).
The second study compared RAGWITEK (Short Ragweed Pollen Allergen Extract)
(n=194) to placebo (n=198) in patients 18 to 50 years of age, of whom
approximately 17 percent had mild asthma of a severity that required, at most,
a daily low dose of an inhaled corticosteroid, and 78 percent were sensitized
to other allergens in addition to short ragweed. The results of Study 2 were
similar to Study 1. Patients treated with RAGWITEK experienced significant
reduction of nasal and ocular symptoms, and significant reduction in use of
symptom-relieving allergy medication, as measured by decrease in the TCS for
the peak ragweed pollen season compared to placebo; difference of RAGWITEK
(n=152) relative to placebo (n=169) was -24 percent (95% CI: -36.5%; -11.3%).
About allergic rhinitis due to short ragweed pollen
It is estimated that approximately 4.5 million adults ages 20 to 64 in the
U.S. have been diagnosed with moderate to severe allergic rhinitis and are
sensitized to short ragweed pollen.
Important safety information about RAGWITEK
WARNING: SEVERE ALLERGIC REACTIONS
RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and
severe laryngopharyngeal restriction. Do not administer RAGWITEK to patients
with severe, unstable or uncontrolled asthma. Observe patients in the office
for at least 30 minutes following the initial dose. Prescribe auto-injectable
epinephrine, instruct and train patients on its appropriate use, and instruct
patients to seek immediate medical care upon its use. RAGWITEK may not be
suitable for patients with certain underlying medical conditions that may
reduce their ability to survive a serious allergic reaction. RAGWITEK may not
be suitable for patients who may be unresponsive to epinephrine or inhaled
bronchodilators, such as those taking beta-blockers.
RAGWITEK is contraindicated in patients with severe, unstable, or uncontrolled
asthma; a history of any severe systemic allergic reaction; a history of any
severe local reaction after taking any sublingual allergen immunotherapy; a
history of eosinophilic esophagitis; or hypersensitivity to any of the
inactive ingredients (gelatin, mannitol and sodium hydroxide) contained in the
RAGWITEK can cause systemic allergic reactions including anaphylaxis which may
be life-threatening and severe local reactions, including laryngopharyngeal
swelling, which can compromise breathing and be life-threatening. Educate
patients to recognize the signs and symptoms of these allergic reactions and
instruct them to seek immediate medical care and discontinue therapy should
any of these occur. Allergic reactions may require treatment with epinephrine.
Prescribe auto-injectable epinephrine to patients receiving RAGWITEK (Short
Ragweed Pollen Allergen Extract). Instruct patients to recognize the signs and
symptoms of a severe allergic reaction and in the proper use of emergency
auto-injectable epinephrine. Instruct patients to seek immediate medical care
upon use of auto-injectable epinephrine and to stop treatment with RAGWITEK.
Review the epinephrine package insert for complete information.
Administer the initial dose of RAGWITEK in a healthcare setting under the
supervision of a physician with experience in the diagnosis and treatment of
allergic diseases and prepared to manage a life-threatening systemic or local
allergic reaction. Observe patients in the office for at least 30 minutes
following the initial dose of RAGWITEK.
Patients who have persistent and escalating adverse reactions in the mouth or
throat should be considered for discontinuation of RAGWITEK.
Eosinophilic esophagitis has been reported in association with sublingual
tablet immunotherapy. Discontinue RAGWITEK and consider a diagnosis of
eosinophilic esophagitis in patients who experience severe or persistent
gastro-esophageal symptoms including dysphagia or chest pain.
RAGWITEK has not been studied in patients with moderate or severe asthma.
Immunotherapy with RAGWITEK should be withheld if the patient is experiencing
an acute asthma exacerbation. Reevaluate patients who have recurrent asthma
exacerbations and consider discontinuation of RAGWITEK.
RAGWITEK has not been studied in patients who are receiving concomitant
allergen immunotherapy. Concomitant dosing with other allergen immunotherapy
may increase the likelihood of local or systemic adverse reactions to either
subcutaneous or sublingual allergen immunotherapy.
Stop treatment with RAGWITEK to allow complete healing of the oral cavity in
patients with oral inflammation (e.g., oral lichen planus, mouth ulcers or
thrush) or oral wounds, such as those following oral surgery or dental
The most common adverse reactions reported in patients 18 years of age and
older treated with RAGWITEK vs. placebo included throat irritation (16.6% vs.
3.3%), oral pruritus (10.9% vs. 2.0%), ear pruritus (10.4% vs. 1.1%) and oral
paraesthesia (10.0% vs. 4.0%).
Because systemic and local adverse reactions with immunotherapy may be poorly
tolerated during pregnancy, RAGWITEK should be used during pregnancy only if
Find an Allergy Specialist
To find an allergy specialist, please visit the websites of the American
Academy of Allergy, Asthma, and Immunology (AAAAI); American College of
Allergy, Asthma & Immunology (ACAAI); or American Academy of Otolaryngic
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# # #
Please see Prescribing Information, including Boxed Warning, for RAGWITEK
[Short Ragweed Pollen Allergen Extract] Tablet for Sublingual Use at
Medication Guide for RAGWITEK at
RAGWITEK™ ^ is a registered trademark of Merck & Co., Inc., Whitehouse
Station, N.J., USA.
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-423-6595
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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