Pimecrolimus (Page 4 of 6)

14 CLINICAL STUDIES

Three randomized, double-blind, vehicle-controlled, multi-center, Phase 3 trials were conducted in 589 pediatric subjects ages 3 months to 17 years old to evaluate pimecrolimus cream, 1% for the treatment of mild to moderate atopic dermatitis. Two of the three trials support the use of pimecrolimus cream, 1% in subjects 2 years and older with mild to moderate atopic dermatitis [see Warnings and Precautions (5.1)]. Three other trials in 1,619 pediatric and adult subjects provided additional data regarding the safety of pimecrolimus cream, 1% in the treatment of atopic dermatitis. Two of these other trials were vehicle-controlled with optional sequential use of a medium potency topical corticosteroid in pediatric subjects and one trial was an active comparator trial in adult subjects with atopic dermatitis [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Two identical 6-week, randomized, vehicle-controlled, multi-center, Phase 3 trials were conducted to evaluate pimecrolimus cream, 1% for the treatment of mild to moderate atopic dermatitis. A total of 403 pediatric subjects 2 to 17 years old were included in the trials. The male/female ratio was approximately 50% and 29% of the subjects were African American. At trial entry, 59% of subjects had moderate disease and the mean body surface area (BSA) affected was 26%. About 75% of subjects had atopic dermatitis affecting the face and/or neck region. In these trials, subjects applied either pimecrolimus cream, 1% or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. At endpoint, based on the physician’s global evaluation of clinical response, 35% of subjects treated with pimecrolimus cream, 1% were clear or almost clear of signs of atopic dermatitis compared to only 18% of vehicle-treated subjects. More pimecrolimus cream, 1% subjects (57%) had mild or no pruritus at 6 weeks compared to vehicle subjects (34%). The improvement in pruritus occurred in conjunction with the improvement of the subjects’ atopic dermatitis.

In these two 6-week trials of pimecrolimus cream, the combined efficacy results at endpoint are presented in Table 2 as follows:

Table 2. Combined Efficacy Results at Endpoint for Two 6-week Trials of Pimecrolimus Cream, 1%

% Subjects

Pimecrolimus Cream (N= 267)

Vehicle (N= 136)

Global Assessment

Clear

28 (10%)

5 (4%)

Clear or Almost Clear

93 (35%)

25 (18%)

Clear to Mild Disease

180 (67%)

55 (40%)

In the two pediatric trials that independently support the use of pimecrolimus cream, 1% in mild to moderate atopic dermatitis, a significant treatment effect was seen by day 15. Of the key signs of atopic dermatitis, erythema, infiltration/papulation, lichenification, and excoriations were reduced at day 8 when compared to vehicle.

Figure 1 depicts the time course of improvement in the percent body surface area affected as a result of treatment with pimecrolimus cream, 1% in 2 to 17 year olds.

Figure 1

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Figure 2 shows the time course of improvement in erythema as a result of treatment with pimecrolimus cream, 1% in 217 year olds.

Figure 2

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(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Pimecrolimus Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams.

30 gram tube………………………………… NDC 68462-609-35

60 gram tube………………………………… NDC 68462-609-65

100 gram tube……………………………….. NDC 68462-609-94

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide)

Patients using pimecrolimus cream, 1% should receive the following information and instructions:

Pimecrolimus cream, 1% may cause serious side effects. It is not known if pimecrolimus cream, 1% is safe to use for a long period of time. A very small number of people who have used pimecrolimus cream, 1% have had cancer (for example, skin or lymphoma). However, a link with pimecrolimus cream, 1% use has not been shown. Because of this concern:
A patient should not use pimecrolimus cream, 1% continuously for a long time.
Pimecrolimus cream, 1% should be used only on areas of skin that have eczema.
Pimecrolimus cream, 1% is not for use on a child under 2 years old.
A patient should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with pimecrolimus cream, 1%.
A patient should limit sun exposure during treatment with pimecrolimus cream, 1% even when the medicine is not on the skin. If a patient needs to be outdoors after applying pimecrolimus cream, 1%, the patient should wear loose fitting clothing that protects the treated area from the sun. The physician should advise the patient about other types of protection from the sun.
A patient should not cover the skin being treated with bandages, dressings or wraps. A patient can wear normal clothing.
Pimecrolimus cream, 1% is for use on the skin only. Do not get pimecrolimus cream, 1% in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get pimecrolimus cream, 1% in any of these areas, burning or irritation can happen. Wipe off any pimecrolimus cream, 1% from the affected area and then rinse the area well with cold water. Pimecrolimus cream, 1% is for external use only.
A patient should use pimecrolimus cream, 1% for short periods, and if needed, treatment may be repeated with breaks in between.
Wash hands before using pimecrolimus cream, 1%. When applying pimecrolimus cream, 1% after a bath or shower, the skin should be dry.
Apply a thin layer of pimecrolimus cream, 1% only to the affected skin areas, twice a day, as directed by the physician.
Use the smallest amount of pimecrolimus cream, 1% needed to control the signs and symptoms of eczema.
A patient should not bathe, shower or swim right after applying pimecrolimus cream, 1%. This could wash off the cream.
A patient can use moisturizers with pimecrolimus cream, 1%. They should be sure to check with the physician first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important they keep up good skin care practices. If a patient uses moisturizers, he or she should apply them after pimecrolimus cream, 1%.

Manufactured by:

Glenmark Pharmaceuticals Ltd.

Plot No. 2, Phase-2, Pharma Zone SEZ,

Pithampur, Dist.-Dhar

Madhya Pradesh 454 775, India

Manufactured for:

R:\Regulatory Affairs 2\ANDAs\Pimecrolimus cream 1% (211769)\Labeling\jpeg files\logo.jpg

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

November 2018

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