RAGWITEK is the First and Only FDA Approved
Sublingual Allergen Immunotherapy Tablet Indicated for the
Treatment of Short Ragweed Pollen Allergies
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 respiratory
portfolio.”
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 Extract)
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.
Study 1:
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%).
Study 2:
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
product.
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 extraction.
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 clearly needed.
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 Allergy (AAOA).
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies, and consumer care and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook and
YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2013 Annual
Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
# # #
Please see Prescribing Information, including Boxed Warning,
for RAGWITEK [Short Ragweed Pollen Allergen Extract] Tablet for
Sublingual Use at
http://www.merck.com/product/usa/pi_circulars/r/ragwitek/ragwitek_pi.pdf
and Medication Guide for RAGWITEK at
http://www.merck.com/product/usa/pi_circulars/r/ragwitek/ragwitek_mg.pdf.
RAGWITEK™ is a registered trademark of Merck &
Co., Inc., Whitehouse Station, N.J., USA.
MerckMedia Contacts:Pamela Eisele, 267-305-3558Robert Consalvo,
908-423-6595orInvestor Contacts:Carol Ferguson, 908-423-4465Justin
Holko, 908-423-5088
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