Merck KGaA announced that its US affiliate, EMD Serono, Inc., received US Food and Drug Administration (FDA) approval of easypod, an innovative delivery system for the administration of Saizen [somatropin (rDNA origin) for injection], a treatment for growth hormone deficiency.
The first of its kind device in this therapeutic area, easypod was designed in conjunction with patients and healthcare professionals for ease of daily use, reliability and convenience.
"In today's high-technology world, it is necessary to continue to innovate by developing delivery systems with easy-to-use settings and real-time data that empower patients and healthcare professionals to help improve patient care," said Fereydoun Firouz, CEO and president, EMD Serono. "easypod is an example of our commitment to breakthrough thinking and technology designed to answer unmet patient and caregiver needs."
In developing easypod, patients, caregivers and healthcare professionals were surveyed for input on how to improve upon delivery systems for growth hormone therapy. The device was designed to help patients administer a subcutaneous daily injection, reliably and in just three simple steps. A key feature of easypod is preset dosing, which means that patients no longer have to set their dose every day. It also tracks the number of doses administered, allowing physicians to monitor patient adherence to therapy.
easypod is intended for use with Saizen click easy cartridges after training from a healthcare provider. Although infrequent, injection site reactions can occur.
In the US, Saizen is indicated for the treatment of children and adults with growth hormone deficiency. Saizen should not be used in patients with active malignancy, diabetic retinopathy, or in Prader-Willi syndrome patients with severe obesity or respiratory impairment.
Merck Serono also offers the only needle-free drug delivery device for growth hormone. Cool click, exclusively for use with Saizen, lessens the fear and anxiety that patients may experience with subcutaneous injections. One click is the first auto-injector pen with a hidden needle for growth hormone in the US and allows the insertion of the needle and injection of medication all in one step, with the simple click of a button.
Growth hormone deficiency occurs when the pituitary gland in the brain is unable to release or produce adequate amounts of growth hormone. In children, growth hormone deficiency causes slow growth, and without treatment, few will reach their full height potential as an adult.
It is estimated that the incidence of growth hormone deficiency in children is between 1 in 4,000 and 1 in 10,000.
Adult growth hormone deficiency can also be a significant problem. More than 50,000 adults in the United States are growth hormone deficient, and 6,000 new cases are reported each year. It is recognized as a specific clinical syndrome.