Ferring Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON^® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.

Adult growth hormone deficiency (GHD) occurs in approximately 1-2 adults per 100,000 and can be a continuation of childhood onset growth hormone deficiency or have an onset in adulthood resulting primarily from trauma, surgery or radiation to the head.ⁱ GHD in adults is characterized by metabolic dysfunction, reduced physical strength and activity, altered lipid metabolism and increases in body fat.ⁱⁱ

ZOMACTON is also indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

"This expanded indication offers an important option that I can now offer my adult patients who need human growth hormone treatment," said Ron Rosenfeld, MD, Professor and Chair of Pediatrics (Emeritus), Oregon Health & Science University.

In 2015, the FDA granted approval for ZOMACTON to be marketed in the U.S. for injection and its needle-free delivery system as ZOMA-Jet^®. Ferring developed and has marketed ZOMACTON outside of the U.S. since 1988 and in 47 countries globally.

ZOMACTON continues to be available by prescription in the U.S., offering both 5 and 10 milligram (mg) options, with the 10 mg dose in a pre-filled diluent syringe. In addition, the ZOMA-Jet needle-free administration device is also available for the 5 mg dose.

"Ferring is committed to developing treatments that improve people's lives," said Paul Navarre, CEO, Ferring Holding Inc. "We are pleased to add the adult indication to our existing endocrinology portfolio."

Consistent with the Ferring Philosophy that "People come first," Ferring is offering ZoGo support services to new adult ZOMACTON^® patients, providers and caregivers. The ZoGo program has been in place since 2015. For more information, call 1-844-944-ZOGO (9646).

About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology, women's health and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com or www.ZOMACTON.com

About ZOMACTON^®

ZOMACTON^® (somatropin) for Injection is a recombinant human growth hormone (GH) indicated for:

• Treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous GH.
• Replacement of endogenous GH in adults with GH deficiency.

Important Safety Information

CONTRAINDICATIONS

ZOMACTON^® is contraindicated in patients with:

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or with acute respiratory failure due to the risk of increased mortality.
• Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of death.
• Active malignancy due to an increased risk of second neoplasm.
• Hypersensitivity to ZOMACTON^®, its excipients, or diluents.
• Active proliferative or severe non-proliferative diabetic retinopathy.
• Pediatric patients with closed epiphyses.

WARNINGS AND PRECAUTIONS

• Increased Risk of Neoplasm: An increased risk of a second neoplasm has been reported in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence or have a history of GH deficiency secondary to an intracranial neoplasm.
• Glucose Intolerance and Diabetes Mellitus: ZOMACTON^® may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Monitor glucose levels periodically in all patients, especially in patients with existing diabetes mellitus or at risk for development. Doses of antidiabetic agents may require adjustment.
• Intracranial Hypertension: Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients. Fundoscopic examination should be performed before initiating treatment and periodically. Stop treatment if papilledema occurs.
• Hypersensitivity: Serious hypersensitivity reactions including anaphylactic reactions and angioedema may occur when using somatropin products. Seek prompt medical attention if an allergic reaction occurs.
• Fluid Retention: Fluid retention may occur in adults and may be dose-dependent.
• Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
• Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may occur or worsen.
• Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur. Evaluate patients with onset of a limp or hip/knee pain.
• Progression of Preexisting Scoliosis in Pediatric Patients: Progression of scoliosis can occur. Patients with a history of scoliosis should be monitored.
• Pancreatitis: Pancreatitis has been reported and should be considered in patients with abdominal pain, especially pediatric patients.
• Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Serious and fatal reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including the diluent for ZOMACTON^® 5 mg vial. Reconstitute with normal saline, if administering ZOMACTON^® 5 mg to infants.
• Lipoatrophy: Injection sites should be rotated to avoid tissue atrophy.

ADVERSE REACTIONS

Most common adverse reactions (10% or greater incidence) in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, parethesia, myalgia, pain, rhinitis, peripheral edema, back pain, flu syndrome, and AST increased.

DRUG INTERACTIONS

• Glucocorticoids: Patients treated with glucocorticoids may require an increased dose.
• Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Should be carefully adjusted in pediatric patients to avoid hypoadrenalism or an inhibitory effect on growth.
• Cytochrome P450-Metabolized Drugs: Monitor carefully if used with ZOMACTON^® as clearance may be altered.
• Oral Estrogen: Larger doses of ZOMACTON^® may be required.
• Insulin and/or Other Hypoglycemic Agents: Dose adjustment may be required.

USE IN SPECIFIC POPULATIONS

• Pregnancy and Lactation: If ZOMACTON^® 5 mg is needed, reconstitute with normal saline, or use the ZOMACTON^® 10 mg benzyl alcohol-free formulation.

ZOMACTON^® and ZOMA-Jet^® are registered trademarks of Ferring B.V.

ⁱ Manthan Life Sciences Consulting Report for Ferring. June 22, 2017.

ⁱⁱ Attanasio AF, Lamberts SW, Matranga AM. Adult growth hormone (GH) deficient patients demonstrate heterogeneity between childhood onset and adult onset before and during human GH treatment. J Clin Endocrinol Metab. 1997 Jan;82(1):82-8.

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