Market Overview

FDA Approves New Indications for ZOMACTON® (somatropin) as Ferring Plans Launch of Needle-Free Delivery System

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  • ZOMACTON now approved for 5 pediatric and 1 adult indication
  • Ferring will launch ZOMA-Jet®
    10 Needle-Free Delivery System for ZOMACTON in September

Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug
Administration (FDA) has approved ZOMACTON (somatropin) for injection in
four additional pediatric indications:

  • Idiopathic short stature (ISS)
  • Short stature associated with Turner syndrome
  • Short stature born small for gestational age (SGA) with no catch-up
    growth by 2 to 4 years
  • Short stature or growth failure in short stature homeobox-containing
    gene (SHOX) deficiency

ZOMACTON was previously approved to treat growth failure in pediatric
patients due to inadequate secretion of endogenous growth hormone (GH)
and replacement of endogenous GH in adults with GH deficiency. Along
with these approvals, Ferring announced plans to launch the ZOMA-Jet 10
Needle-Free Delivery System for ZOMACTON in September.

It is estimated that around 3-5% of children in the United States have
short stature, defined as a height below the 3rd percentile. Patients
with short stature typically present with below average height in
relation to their age, sex, racial group, or family.1 Today,
the majority of treatments for these diseases involve needles. However,
in a recent study, over 60% of children ages 6-17 expressed a fear of
needles.2

"Parents struggle to deliver their child's daily dose of growth
hormone due to children's fear and anxiety of needles
," said Teresa
Tucker, Co-Founder and Patient Advocate of The MAGIC Foundation. "Parents
and patients will welcome an option that is completely needle free
."

From September, ZOMACTON will be available to use with the ZOMA-Jet 10
Needle-Free Delivery System. ZOMA-Jet 10 will provide the only
completely needle-free delivery option available for children being
treated with growth hormone.

ZOMACTON is available by prescription in the U.S., offering both 5 and
10 milligram (mg) options. Ferring developed ZOMACTON and currently
markets it in 47 countries globally.

"We are expanding the Ferring endocrinology portfolio with new
indications and a delivery system to meet patient needs,"
said Paul
Navarre, CEO, Ferring Holding Inc. (US). "Many patients object to
needles, no matter how small. Ferring will now offer the only completely
needle-free option for treating these diseases."

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

You are encouraged to report negative side effects of prescription drugs
to FDA. Visit www.FDA.gov/medwatch,
or call 800.FDA.1088.

For full prescribing information, please visit: www.ferringusa.com/pi/zomacton

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.

FERRING, the FERRING PHARMACEUTICALS logo, and ZOMACTON and ZOMA-Jet 10
are trademarks of Ferring B.V.

About ZOMACTON®

Indications:
ZOMACTON is a recombinant human growth hormone
indicated for the treatment of pediatric patients with:

  • growth failure due to inadequate secretion of endogenous growth
    hormone (GH)
  • short stature associated with Turner syndrome
  • idiopathic short stature (ISS)
  • short stature or growth failure in short stature homeobox-containing
    gene (SHOX) deficiency
  • short stature born small for gestational age (SGA) with no catch-up
    growth by 2 to 4 years

ZOMACTON is also indicated for the replacement of endogenous GH in
adults with GH deficiency.

Important Safety Information
CONTRAINDICATIONS
ZOMACTON
is contraindicated in patients with:

  • Acute critical illness
  • 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.
  • 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: Second neoplasms have occurred in
    childhood cancer survivors. Monitor patients with preexisting tumors
    for progression or recurrence.
  • Glucose Intolerance and Diabetes Mellitus: ZOMACTON may
    decrease insulin sensitivity, particularly at higher doses. Monitor
    glucose levels periodically, especially in patients with existing
    diabetes mellitus or at risk for development.
  • Intracranial Hypertension (IH): Has been reported usually
    within 8 weeks of initiation. Perform fundoscopic examinations prior
    to initiation and periodically thereafter. If papilledema occurs, stop
    treatment.
  • Hypersensitivity: Serious hypersensitivity reactions may occur,
    seek prompt medical attention.
  • 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 after initiation of somatropin.
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: May
    occur; evaluate patients with onset of a limp or hip/knee pain.
  • Progression of Preexisting Scoliosis in Pediatric Patients:
    Monitor patients with scoliosis for progression.
  • Pancreatitis: Has been reported; consider pancreatitis in
    patients with abdominal pain, especially pediatric patients.
  • Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol
    Preservative:
    Serious and fatal adverse reactions can occur in
    neonates and infants treated with benzyl alcohol-preserved drugs,
    including the diluent for ZOMACTON 5 mg. If administering ZOMACTON 5
    mg to infants, reconstitute with 0.9% sodium chloride injection.

ADVERSE REACTIONS
Common adverse reactions reported include:
upper respiratory infection, fever, pharyngitis, headache, otitis media,
edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome,
peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and
impaired glucose tolerance.

DRUG INTERACTIONS

  • Glucocorticoids: Patients treated with glucocorticoids may
    require an increased dose.
  • Pharmacologic Glucocorticoid Therapy and Supraphysysiologic
    Glucocorticoid Treatment:
    Adjust dosing 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 0.9% sodium chloride injection or use the ZOMACTON®
    10 mg benzyl alcohol-free formulation.

References

1 Argente J. Challenges in the Management of Short Stature.
Horm Res Paediatr. 2016;85(1):2-10.

2 Orenius T, Mikola K, Ristolainen L. Fear of Injections and
Needle Phobia Among Children and Adolescents: An Overview of
Psychological, Behavioral, and Contextual Factors. SON

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