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HomeAbout NGENLAEfficacySafetyEfficacy & SafetyEfficacy & SafetyPhase III Pivotal Trial & Open Label ExtensionPhase II Dose Finding StudyDosingDosingDosing & AdministrationMyNgenla PlanSupport and ServicesSupport and ServicesMaterialsVideosPatient Support
Prescribing InformationIndication Patient Site

Efficacy-Pivotal

Efficacy-OLE

Safety

Once-weekly NGENLA delivered efficacy similar to daily GH with ~85% fewer doses1,2Efficacy demonstrated comparable to daily GH at 1 year (N=224)1 Phase 3 Study Design and End Points Explore the study Loading Primary end point1
  • AHV in cm/year after 12 months of treatment
Key secondary end points2
  • These post hoc results should be interpreted with caution because the analysis was not prespecified and therefore potentially subject to a greater degree of bias
  • Change in height standard deviation score (SDS) at 6 and 12 months, compared to baseline    
    • Least square mean change at 6 months: 0.54 vs 0.48 with NGENLA vs GENOTROPIN®, respectively
      • The data provided as 6 months is descriptive only, conclusions cannot be drawn.
    • Least square mean change at 12 months: 0.92 vs 0.87 with NGENLA
vs GENOTROPIN®, respectively
  • Mean insulin-like growth factor 1 (IGF-1) and IGF-1 SDS levels after dosing with NGENLA
    • Mean change from baseline in IGF-1 at 12 months: 126 ng/mL
    • Mean IGF-1 SDS at month 12 post baseline was 0.65
IGF-1 was to be measured on day 4 (96 hours) post dose, as this interval has been shown to provide the best estimate of the mean IGF-1 value over the dosing interval of 1 week in this
post hoc analysis. As patients had samples drawn at variable days post dose, a model was developed to calculate estimated mean IGF-1 SDS values from sampling over the dosing
interval (1 week), regardless of the timing of IGF-1 measurement since last dose.3  Mean increase in height SDS                                                                                                                                                                        Modeled SDS IGF-1 normalization over 1 year with NGENLA2,3Three patients had a mean IGF-1 SDS of ≥2; no patients had IGF-1 SDS ≥3.3References:NGENLA. Prescribing information. Pfizer Inc.; 2023.Data on file. Pfizer Inc., New York, NY.Deal CL. Results of global phase 3 study of once-weekly somatrogon in growth hormone deficient children.
Presented at: ENDO Online 2020; June 8-22, 2020.
Once-weekly NGENLA Phase 3 OLE study design1Study design2
  • Open-label, single-arm extension, phase 3 study continuation of the randomized 12-month study
Dosing1
  • Patients who received NGENLA during the phase 3 study continued with the same dose during the OLE
  • Patients who received GENOTROPIN® during the phase 3 study were switched to NGENLA and began treatment with a dose of 0.66 mg/kg/week
  • The dose of NGENLA can be adjusted every 3 months based on the patient's body weight and may be decreased for safety reasons based on predefined dose-adjustment criteria
End points2†
  • AHV, change in height SDS
  • IGF-1 levels and IGF-1 SDS assessed on day 4 after NGENLA dosing across study visits
Study participants1
  • 212 patients completed the phase 3 study and enrolled in the OLE
  • Patients who received NGENLA in the phase 3 study continued to receive NGENLA 0.66 mg/kg/week (n=104)
  • Patients who received GENOTROPIN® in the phase 3 study were switched to NGENLA 0.66 mg/kg/week (n=108)
Key inclusion criteria2
  • Patients who completed the phase 3 study and provided their consent were eligible to be enrolled
Mean AHV for patients who switched to once-weekly NGENLA after 1 year of the phase 3 OLE3Study limitations3

The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.

These efficacy data represent the pivotal study year (year 1), as well as the first 3 years of the phase 3 OLE (year 2, year 3, and year 4). Statistical analyses of the data for Years 2, 3 and 4 are descriptive only, and no formal hypothesis testing was performed.3

Mean height SDS at month 12 of each study year3Study limitations3

The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.

These efficacy data represent the pivotal study year (year 1), as well as the first 3 years of the phase 3 OLE (year 2, year 3, and year 4). Statistical analyses of the data for Years 2, 3 and 4 are descriptive only, and no formal hypothesis testing was performed.3

Change in mean height SDS (from baseline) at month 12 of each study year3Study limitations3

The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.

These efficacy data represent the pivotal study year (year 1), as well as the first 3 years of the phase 3 OLE (year 2, year 3, and year 4). Statistical analyses of the data for Years 2, 3 and 4 are descriptive only, and no formal hypothesis testing was performed.3

OLE, open-label extension0.034 mg/kg/day is the equivalent of 0.24 mg/kg/week.Efficacy and safety were assessed every 3 months for the first year of OLE.References:Data on file. Pfizer Inc., New York, NY. Wajnrajch M, Miller BS, Steelman J, et al. Switch data from the open-label extension of the pivotal phase 3 study of once weekly somatrogon compared with daily somatropin in pediatric patients with growth hormone deficiency (GHD). Poster presented at: Annual Meeting of the Endocrine Society 2021; March 20-23, 2021. Poster 7129.Steelman J et al. Poster presented at: 2024 Pediatric Endocrine Society Annual Meeting; May 2-5, 2024. Poster 21. NGENLA. Prescribing information. Pfizer Inc.; 2023.
Phase 3 Pivotal Study Safety Results1Majority of adverse reactions were mild to moderate in severity2Summary of all-causality TEAEs return
(Main Study and OLE)2

AE, adverse event; OLE, open-label extension.
Adverse reactions that are medically related were grouped to a single preferred term.

Injection site reactions included: injection site pain (39% NGENLA vs 25% daily GENOTROPIN®), injection site swelling/induration/hypertrophy/inflammation (10% NGENLA vs 1% daily GENOTROPIN®), injection site erythema (8% NGENLA vs none daily GENOTROPIN®), injection site pruritus (5% NGENLA vs none daily GENOTROPIN®), injection site hemorrhage (5% NGENLA vs none daily GENOTROPIN®).Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis.Discontinuation due to injection site erythema and induration.References:Steelman J et al. Poster presented at: 2024 Pediatric Endocrine Society Annual Meeting; May 2-5, 2024. Poster 21. Data on file. Pfizer Inc., New York, NY. NGENLA. Prescribing information. Pfizer Inc.; 2023.
Efficacy & Safety Dosing

Once-weekly administration with a multidose, prefilled pen.◊

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INDICATION NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
Important Safety Information CONTRAINDICATIONS
Somatrogon is contraindicated in patients with acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with growth hormones. 

NGENLA is contraindicated in patients with hypersensitivity to somatrogon or any of its excipients.

Somatrogon is contraindicated in patients with closed epiphyses.

Somatrogon is contraindicated in patients with active malignancy due to the risk of malignancy progression. 

Somatrogon is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Somatrogon is contraindicated in 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 sudden death.

WARNINGS AND PRECAUTIONS
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin. The safety of continuing NGENLA treatment for the approved indication who concurrently develop these illnesses has not been established.

Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and caregivers that such reactions are possible and that prompt medical attention should be sought if allergic reaction occurs.

There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment should be completed, prior to instituting therapy with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy.

In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on NGENLA therapy for progression or recurrence of the tumor.

Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms.

Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in skin pigmentation or changes in the appearance of preexisting nevi.

Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving NGENLA, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when NGENLA is initiated.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first 8 weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved. 

Fluid retention during NGENLA therapy may occur. Clinical manifestations of fluid retention (eg, edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.

Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. 

Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain.

NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Growth hormone treatment has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.

Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain.

When growth hormone is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering NGENLA to reduce this risk.

There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. If a patient is found to have abnormal laboratory tests, monitor as appropriate.

ADVERSE EFFECTS
Adverse reactions reported in ≥5% of patients treated with NGENLA are injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain. Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all NGENLA devices.Indication NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

Please see full Prescribing Information.