**Statement by Jennifer Merenda, RN**

**7 Perch Court**

**Baltimore, MD 21220**

**(410) 344-1058**

# merendaj@yahoo.com

**To the Food and Drug Administration Pulmonary-Allergy Drugs Advisory
Committee**

**Re: BLA 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to
Human IgE) by Genentech, Inc., for the treatment of allergic asthma**

**May 15, 2003**

**Holiday Inn**

**The Ballrooms**

**Two Montgomery Village Avenue**

**Gaithersburg, MD**

Good afternoon. Thank you for your time today on this very important
issue and thank you for allowing me to testify before your Committee. My
name is Jennifer Merenda. I am a registered nurse with the R. Adams
Cowley Shock Trauma hospital in Baltimore, MD, a wife, and a mother of
two children. My comments today are on my own behalf and on behalf of my
son, who also has asthma. The Asthma and Allergy Foundation of America
has helped make my presence here today possible.

I have been waiting three very long years to tell you my story.

Since birth, I have had restricted airway problems. I spent the first
two weeks of my life in the hospital because of breathing difficulties.
I spent most of my early childhood years restricted in my activities, as
medication to treat my chronic symptoms was not available. Instead,
avoidance was supposed to be the best treatment, which was good in
theory but was not practical in real life, especially for a child. I
awakened many nights suffering with shortness of breath and made
frequent retreats to my parents' room for assistance. I spent every
Wednesday afternoon and every Saturday morning in my doctor\'s office
for a minimum of one and a half hours while I received my allergy serum
injection. I endured tenderness and swelling at the site that resembled
an egg beneath the skin surface. Winter nights were spent in my bedroom
with a vaporizer and frequent chest physiotherapy. I would be sent home
from school because I \"looked\" like I was having too much trouble
breathing, even as I pleaded to stay.

I stopped allergy injections in my early teens as there did not seem to
be any real benefit. I began to use Primatine Mist as that was the most
useful over-the-counter medication at the time. I grew tired of the
doctor's office. As I grew into my late teens my breathing and allergies
worsened. I was tired of medicine. I was tired of reading every food
label. I was always taught to deal with my health problems and not use
asthma as an excuse. I didn't want sympathy from anyone. I would rather
enjoy life, wheeze, take my inhaler and move on. I guess that was part
of being a teen.

At the age of 17, I finally realized that my asthma was not controlled.
I began my allergy injections again and was prescribed Theopholine twice
a day with Ventolin for breakthrough wheezing. While both drugs
certainly helped my asthma, I experienced several side effects.
Eventually I changed to a sustained release form of the Theopholine and
had more control, but again, not without the side effects. Along came
Serevent, and though I continued to have my problems, I felt it was
under control. Little did I know what control could be, however, until a
friend of mine with asthma told me about a new clinical trial.

When I joined the Xolair trial in August of 1998, I was told the FDA did
not yet approve the drug being tested, but that if I got the drug
instead of placebo I would most certainly see improvement. Truth is, I
didn't feel like I had anything to lose and my expectations were quite
low. To qualify for the trial, I had to stop current medications. This
was the most difficult part, as I had to restrict my activities because
of shortness of breath. I couldn't even walk a flight of stairs.

I can't emphasize enough for you my surprise with this miracle injection
I began to receive. I did not experience any local effects at the
injection site and my asthma symptoms were completely alleviated. While
I received the Xolair injections, I experienced the life of a normal
person. I say this because prior to Xolair, people in my life would say
\"you\'re breathing heavy again\" or \"I can hear you coming around the
corner before I see you.\"

With Xolair, I stopped clearing my throat and coughing frequently. I
could go anywhere without the fear of losing my inhaler. I was no longer
concerned about needing to have an inhaler in every coat, in every pair
of pants, in my car, or in a relative's home. I was not afraid to go on
vacation and be without a nebulizer machine. I did not make noise
breathing. I slept quietly. I did not walk around with my mouth open. I
did not have to worry about restrictive clothing. My nose worked and was
no longer what I refer to as \"purely cosmetic\...serving no function.\"
I was truly free. For the first time in my life, I felt like everyone
else did not have his or her \"eyes of concern\" focused on me.

I told you in the beginning that I've waited three long years to tell
you my story. That's because when the Xolair clinical trial ended three
years ago, I immediately returned to a life of daily asthmatic symptoms.
I felt I had something great and now it's gone. I am a registered nurse.
I work in a center that is known worldwide. I continue to praise this
miracle drug to physicians and colleagues that I work with daily. I
field questions from other patients about the drug that once relieved me
from the misery of my asthma.

And as a nurse, I'll be the first to say that prevention is where health
care starts. Prevention is what Xolair is all about as far as I\'m
concerned. The fact is, it is difficult for patients to understand why a
drug that has demonstrated so much promise has not been approved yet. I
continue to be asked by my colleagues, and by my family and friends,
about where the drug is currently in the approval process. I not only
think of myself though. I think about how many emergency room visits for
people with asthma could be eliminated. I think of my son and the
potential for his life to be free from continuous medication and
constant fear. I look to the future and hope that many more people with
asthma will know what it means to lead a normal life. I sincerely
believe Xolair can provide that freedom. I urge you today to recommend
that this drug be approved.

Again, thank you for your time and for allowing me to share my story.