Ipsen to start second resupply of Increlex in the US in September

In collaboration with the US Food and Drug Administration (FDA), Ipsen is releasing a second batch of Increlex in 2014. The first batch was made available for distribution in June of 2014.

"We are pleased that an additional supply of Increlex has been released for distribution to treat pediatric patients with severe primary IGF-1 deficiency, a condition which can cause permanent short stature," said Cynthia Schwalm, President and CEO of Ipsen N.A.

"These children depend on this product for the treatment of this rare and debilitating condition."

Ipsen is committed to working closely with regulators with the goal of ensuring that additional lots of Increlex are made available on a timely basis.

Increlex is used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called severe primary IGF-1 deficiency. Increlex should not be used for other causes of growth failure and should not be used instead of growth hormone.

Increlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (IGFD), or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH. Severe primary IGFD is defined by height standard deviation score = -3.0 and basal IGF-1 standard deviation score = -3.0 and normal or elevated growth hormone (GH).

Increlex is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex treatment. Increlex is not a substitute to GH for approved GH indications. Increlex has not been studied in children < 2 years of age.