ACCOLATE -zafirlukast- Approved by FDA for Children with Asthma Seven Years of Age and Older

Business Wire, Sept 20, 1999

WILMINGTON, Del.--(BUSINESS WIRE)--Sept. 20, 1999--

New, safe treatment option now available to help control

asthma in children

A new pediatric formulation of the popular asthma medication, ACCOLATE(R) (zafirlukast), has received approval from the U.S. Food and Drug Administration (FDA) for use in patients as young as seven years of age.

The product will be available in a 10- milligram, nonflavored minitablet specifically designed for children. Recommended dosing is one 10-mg minitablet twice daily, even during symptom free periods.

Since 1996, ACCOLATE has helped control symptoms for asthma sufferers 12 years of age and older. In the U.S., ACCOLATE has been prescribed more than 5 million times for the preventive and chronic treatment of asthma. ACCOLATE is now approved in 60 countries worldwide.

"The new pediatric indication for ACCOLATE is very important because it offers a new, safe preventive asthma treatment option for children," said Kathy L. Lampl, M.D., Medical Director of Asthma & Allergy Associates, Rockville, Maryland. "Although there is no cure for asthma, parents can now help control their child's asthma with a convenient oral tablet given in the morning and evening."

Asthma in children is becoming more and more prevalent and asthma is the most common chronic medical problem affecting children under 17.(1) An estimated 17 million Americans suffer from asthma, including more than five million children under the age of 18.(2) Since 1980, asthma in very young children has jumped 160 percent.(1)

Asthma is the leading cause of school absence due to chronic illness(3) and children with asthma miss 10 million school days each year.(1) Asthma can be triggered by numerous factors, including pollution, cigarette smoke, house dust mites, cats, cockroaches, and molds. Although no cure exists for asthma, it can be effectively controlled.

Controlling Asthma in Children

"Coping with a child who has asthma can be difficult," said Catherine M. Bonuccelli, M.D., Medical Director, AstraZeneca. "ACCOLATE for children can help control a child's asthma, but it is also important for the family to be well educated about the condition."

ACCOLATE is now indicated for the preventive and chronic treatment of asthma in patients as young as 7 years of age. Dosing for ACCOLATE for children between the ages of 7 and 11 is one 10-mg nonflavored minitablet twice daily, even during symptom free periods.

"The taste of medicines is an important issue for the pediatric population," continues Dr. Bonuccelli, "If a child does not like a particular flavor or becomes tired of one flavor, getting them to take their medicine can become a problem for parents." The 10-mg, nonflavored minitablet of ACCOLATE may help to avoid these types of problems.

ACCOLATE Safety in Children

Safety data from the ACCOLATE pediatric clinical trials, involving nearly 800 pediatric subjects, have shown ACCOLATE to be well-tolerated. The age, sex, race, body weight, or severity of disease of the study population did not affect the tolerability of ACCOLATE.

The adverse event profile for subjects who were treated with ACCOLATE was similar to the profile for subjects treated with placebo and was also similar to that seen in the clinical trials involving subjects aged 12 years and older.

No statistically significant difference in the incidence rates of commonly reported adverse events was found between the ACCOLATE- treated and placebo-treated groups in controlled pediatric clinical trials. The adverse events seen more frequently in pediatric patients treated with ACCOLATE versus placebo were generally mild and included headache (4.5% vs 4.2%) and abdominal pain (2.8% vs 2.3%).

The long-term safety of ACCOLATE in pediatric patients was further confirmed in a 52-week, open label extension trial. The effectiveness of ACCOLATE for the prophylaxis and chronic treatment of asthma in pediatric patients aged 7 to 11 years is based on an extrapolation of the demonstrated efficacy of ACCOLATE in adults with asthma.

Background Information: AstraZeneca and Advancements in the

Treatment of Asthma

In November 1996, Zeneca Pharmaceuticals introduced ACCOLATE(R) (zafirlukast), a leukotriene receptor antagonist or LTRA, which was the first product introduced in the first new class of asthma drugs approved by the Food and Drug Administration in nearly 25 years.

ACCOLATE therapy is an oral controller agent available by prescription only as 10-mg and 20-mg tablets for the prevention and chronic treatment of asthma in adults and children seven years of age and older.

Patients on therapy with ACCOLATE take one tablet in the morning and one tablet in the evening either one hour before or two hours after meals, even during symptom-free periods, to help control asthma symptoms all day and all night. ACCOLATE should not be used to reverse a sudden asthma attack. ACCOLATE tablets are generally well-tolerated by most patients.

Patients should consult with their doctors before changing their current asthma medications, if they are prescribed a blood thinner, if they are nursing, or if their medical condition worsens. Side effects are generally mild including headache, infection(a) and nausea in adults and headache and abdominal pain in pediatric patients. In clinical studies the incidence of these side effects was not significantly different from placebo.