FDA Reviews Allergy Pill

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TRENTON, N.J.
(AP) — Drugmaker Merck & Co. said Wednesday that federal
regulators are reviewing its application to sell a new type of treatment
for grass pollen allergy that gradually reduces allergy symptoms over
time, rather than just temporarily relieving the sneezing and itching.

The
treatment, a tablet that quickly dissolves under the tongue, could
become the first alternative available in the U.S. to getting a long
series of uncomfortable allergy shots. Both methods work by gradually
desensitizing the patient's immune system to the substance triggering
the allergic reaction.

Merck's immunotherapy, still unnamed, would be taken daily throughout allergy season for three years.

The
company said six late-stage studies of the tablet in nearly 3,500
adults and children – conducted during peak spring and summer pollen
season – found that it was safe and effective at reducing grass allergy
symptoms. Those include runny nose, congestion, sneezing and itchy,
watery eyes.

The most common side effects reported were itchiness of the mouth and ear and throat irritation.

“This
product will be used by tens of millions of people,” predicted WBB
Securities analyst Steve Brozak. “Patients will readily adopt it.”

Brozak
said he expects Merck will advertise the therapy heavily to consumers
in hopes of attracting both patients considering allergy shots and the
many more who regularly take prescription or over-the-counter medicines
to relieve symptoms.

Dr. Linda Cox, president
of the American Academy of Allergy, Asthma & Immunology, called
immunotherapy tablets a “major advance” in patient treatment because
they are being developed for multiple common allergy types.

“People
who are now just toughing it out (with symptomatic treatment) will now
have a better option,” she said, and with the treatment “might need an
occasional antihistamine” during grass pollen season, “versus multiple
medications and possibly an asthma flare-up.”

Based
on study data for Merck's experimental treatment and one a French
company has been developing, patients should just need to take an
occasional antihistamine for at least a couple of years after treatment
ends, she said.

Immunotherapy is the only
treatment approach that targets the underlying cause of an allergy to
substances such as pollen, dust mites, stinging insects and pet dander.

Cox
noted about 95 percent of allergy patients just take medicines for
symptoms, while 2 percent to 5 percent – generally those with multiple
serious allergies – have been getting allergy shots.

“There's about 8 million injections given a year,” she noted.

The
shots, injected just under the skin, typically have been given once or
twice a week in increasing doses for 3 to 6 months, followed by a
maintenance period of 3 to 5 years with monthly booster shots. More
recently, allergy specialists have been using the “cluster” technique,
reducing sensitivity faster by giving 2 to 3 dose increases on each of
two weekly visits over a month. That's also followed by a maintenance
period.

Merck, based in Whitehouse Station,
N.J., said it expects the Food and Drug Administration to decide whether
to approve the treatment in the first quarter of next year.

It has been approved for several years in Europe, where it is sold under the brand name Grazax by Merck partner ALK-Abello.

Merck
wouldn't say Wednesday what it expects to charge for the tablets here.
Box noted that when they were launched in Europe in 2006, the price was
2.95 euros per pill, or roughly $3.75 at today's exchange rates.
Patients with insurance getting allergy shots typically have a small
copay, often $5 or less, because a nurse gives the injections, but all
those appointments are time-consuming.

Cox
served as the primary investigator in a clinical trial of another grass
pollen immunotherapy tablet developed by France's Stallergenes S.A. The
FDA accepted that company's application for approval of its experimental
treatment on Feb. 18.

Merck recently applied
to the FDA for approval to sell an immunotherapy tablet for ragweed
pollen. The FDA has not yet determined whether that application is
complete enough to accept for review.

Merck, a
leader in asthma and allergy treatments with medicines including
Singulair, Clarinex and Nasonex, also is doing patient tests of an
immunotherapy tablet for house dust mites.

Copyright 2013 by The Associated Press. All rights reserved.

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