GRASTEK is the Only FDA Approved Sublingual
Allergy Immunotherapy Tablet Indicated for Children as Young as 5
Years of Age
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 GRASTEK® (Timothy Grass Pollen Allergen Extract)
Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)].
GRASTEK is an allergen extract indicated as immunotherapy for the
treatment of grass pollen-induced allergic rhinitis with or without
conjunctivitis confirmed by positive skin test or in vitro testing
for pollen-specific IgE antibodies for Timothy grass or
cross-reactive grass pollens. GRASTEK is approved for use in
persons 5 through 65 years of age. GRASTEK is not indicated for the
immediate relief of allergic symptoms.
The prescribing information for GRASTEK includes a boxed warning
regarding severe allergic reactions. GRASTEK 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.
“Every grass pollen season, many patients with moderate to
severe allergic rhinitis experience nasal and ocular allergy
symptoms at their worst while taking symptom-relieving medication,”
said Dr. David Bernstein, professor of medicine and environmental
health, Division of Immunology, Allergy and Rheumatology,
University of Cincinnati College of Medicine. “These patients often
have multiple sensitivities. Some of these patients may be
candidates for immunotherapy, but decline allergy shots. With the
FDA approval of GRASTEK, allergy specialists now have a new
sublingual approach to offer these patients for their grass
allergies.”
Symptoms of grass pollen-induced allergic rhinitis with or
without conjunctivitis may include sneezing, runny or itchy nose,
stuffy or congested nose, or itchy and watery eyes, and typically
intensify during the grass pollen season.
“The FDA approval of GRASTEK brings an important new sublingual
tablet for allergy specialists treating adults and children with
allergic rhinitis with or without conjunctivitis caused by Timothy
or cross-reactive grass pollens,” said Dr. Sean Curtis, vice
president, Respiratory and Immunology, Merck Research Laboratories.
“This important milestone marks another opportunity for Merck to
build on our respiratory heritage with allergy specialists.”
About Timothy grass allergy
Timothy grass is one of the most common grasses in the United
States and has been demonstrated to be cross-reactive with other
grasses, including sweet vernal, orchard (also known as cocksfoot),
perennial rye, Kentucky blue (also known as June grass), meadow
fescue and redtop. Timing of the grass pollen season varies
regionally across the United States.
Dosing and administration of GRASTEK (Timothy Grass Pollen
Allergen Extract)
The recommended dose of GRASTEK is one tablet daily to be placed
under the tongue, where it will dissolve.
The first dose of GRASTEK 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 GRASTEK 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. Children
must take GRASTEK under adult supervision.
Initiate GRASTEK at least 12 weeks before the expected onset of
each grass pollen season and continue treatment throughout the
season. The safety and efficacy of in-season initiation have not
been established.
For sustained effectiveness for one grass pollen season after
cessation of treatment, GRASTEK may be taken daily for three
consecutive years (including the intervals between the grass pollen
seasons). The safety and efficacy of in-season initiation have not
been established.
GRASTEK will be available in U.S. pharmacies in late April.
About the clinical study program for GRASTEK (Timothy Grass
Pollen Allergen Extract)
The efficacy of GRASTEK was supported by two studies of
approximately 24 weeks treatment duration over one grass season
each in patients 5 through 65 years of age, and one 5-year grass
pollen season study in patients 18 through 65 years of age. In all
three randomized, double-blind, parallel-group, multi-center
studies:
- Patients had a history of grass
pollen-induced allergic rhinitis with or without conjunctivitis,
and sensitivity to grass confirmed by positive skin test or in
vitro testing for pollen-specific IgE antibodies for Timothy
grass;
- Patients with non-grass sensitivities
were included as long as the patients did not require treatment as
a result of symptoms from those non-grass allergies during the
grass season;
- GRASTEK or placebo was administered as
a sublingual tablet and initiated approximately 12 weeks before the
start of the grass 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 scores (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.
First season efficacy in adults and children
One study compared GRASTEK to placebo in 1,501 patients 5
through 65 years of age, of whom approximately 25 percent had mild,
intermittent asthma and 85 percent were sensitized to other
allergens in addition to grass. Patients treated with GRASTEK 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 entire grass pollen season, compared to
placebo; difference for GRASTEK (Timothy Grass Pollen Allergen
Extract) (n=629) relative to placebo (n=672) was -23 percent (95%
CI: -36.0%; -13.0%).
A second study compared GRASTEK to placebo in 344 patients 5
through 17 years of age, of whom 26 percent had mild, intermittent
asthma and 89 percent were sensitized to other allergens in
addition to grass. Patients treated with GRASTEK 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 entire grass pollen season, compared to placebo;
difference for GRASTEK (n=149) relative to placebo (n=158) was -26
percent (95% CI: -38.2%; -10.1%).
Sustained effect
In one 5-year study, 634 patients 18 through 65 years of age
received GRASTEK or placebo for three consecutive years and were
then observed for two years during which they did not receive study
drug. Patients treated with GRASTEK had a decrease in TCS
throughout the grass pollen season during the three years of active
treatment. This effect was sustained during the grass pollen season
in the first year after discontinuation of GRASTEK, but not in the
second year.
TCS difference (GRASTEK relative to placebo) per year:
- Year 1: -34% (95% CI: -42.0%;-26.3%);
(n=568*)
- Year 2: -41% (95% CI: -51.8%;-29.5%);
(n=316*)
- Year 3: -34%;(95% CI: -45.5%;-21.4%);
(n=287*)
- Post Treatment Year 1: -27% (95% CI:
-39.9%;-12.4%); (n=257*)
*Number of patients in analysis in both treatment groups
(GRASTEK and placebo).
About allergic rhinitis due to Timothy and cross-reactive
grasses
It is estimated that approximately 7.5 million U.S. children and
adults ages 5 to 64 have been diagnosed with moderate to severe
allergic rhinitis and are sensitized to Timothy and cross-reactive
grass pollens.
Selected safety information about GRASTEK (Timothy Grass
Pollen Allergen Extract)
WARNING: SEVERE ALLERGIC REACTIONS
GRASTEK can cause life-threatening allergic reactions such as
anaphylaxis and severe laryngopharyngeal restriction. Do not
administer GRASTEK 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.
GRASTEK may not be suitable for patients with certain underlying
medical conditions that may reduce their ability to survive a
serious allergic reaction. GRASTEK may not be suitable for patients
who may be unresponsive to epinephrine or inhaled bronchodilators,
such as those taking beta-blockers.
GRASTEK 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
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.
GRASTEK can cause systemic allergic reactions including
anaphylaxis which may be life-threatening. In addition, GRASTEK can
cause 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 GRASTEK. 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 GRASTEK.
Review the epinephrine package insert for complete information.
Administer the initial dose of GRASTEK 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 GRASTEK.
GRASTEK can cause local reactions in the mouth or throat that
could compromise the upper airway. Consider discontinuation of
GRASTEK in patients who experience persistent and escalating
adverse reactions in the mouth or throat.
Eosinophilic esophagitis has been reported in association with
sublingual tablet immunotherapy. Discontinue GRASTEK (Timothy Grass
Pollen Allergen Extract) and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent
gastro-esophageal symptoms including dysphagia or chest pain.
GRASTEK has not been studied in patients with moderate or severe
asthma or any patients who required daily medication to treat
asthma. Withhold immunotherapy with GRASTEK if the patient is
experiencing an acute asthma exacerbation.
GRASTEK 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 GRASTEK 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 clinical studies
for patients 18 through 65 years of age with Timothy grass
pollen-induced allergic rhinitis with or without conjunctivitis and
treated with GRASTEK vs. placebo included oral pruritus (26.7% vs.
3.5%), throat irritation (22.6% vs. 2.8%), ear pruritus (12.5% vs.
1.1%) and mouth edema (11.1% vs. 0.8%).
The most common adverse reactions for GRASTEK vs. placebo in
clinical studies for pediatric patients between 5 and 17 years of
age with grass pollen-induced allergic rhinitis with or without
conjunctivitis included oral pruritus (24.4% vs. 2.1%), throat
irritation (21.3% vs. 2.5%), and mouth edema (9.8% vs. 0.2%).
Because systemic and local adverse reactions with immunotherapy
may be poorly tolerated during pregnancy, GRASTEK 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); the
American College of Allergy, Asthma & Immunology (ACAAI); or
the 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).
GRASTEK® is a registered trademark of Merck
& Co., Inc., Whitehouse Station, N.J., USA.
Please see Prescribing Information, including Boxed Warning,
for GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for
Sublingual Use at
http://www.merck.com/product/usa/pi_circulars/g/grastek/grastek_pi.pdf
and Medication Guide for GRASTEK at
http://www.merck.com/product/usa/pi_circulars/g/grastek/grastek_mg.pdf.
MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo,
908-423-6595orInvestor:Carol Ferguson, 908-423-4465orJustin Holko,
908-423-5088
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